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GSK Medicine: Non-compound specific

Study Number: 117275

Title: A study to characterise lung function, airway morphometry, pharyngometry and inhalation profiles from patients with Idiopathic Pulmonary Fibrosis (IPF)

Rationale: This study was to provide interval inhalation profiles and lung function for subjects who had a range of clinical severity of IPF over a follow-up period of up to 12 months, and high resolution computed tomography (HRCT) scans over a follow-up period of up to 6 months. Data derived from these measures were to be used to enable the development of more accurate disease specific drug deposition models. Following up subjects with additional HRCT scans at 3 and 6 months enabled the sensitivity of HRCT based criteria of disease progression to be compared with lung function criteria, and assess if HRCT measures could be used to provide a more accurate and sensitive measurement of disease progression.

Phase: I

Study Period: 03-Dec-2013 to 11-Jul-2016

Study Design: This was a phase I, single-centre study, with no administration of investigational product. The subjects with IPF attended the clinic initially for a screening visit. Within 30 days of the screening visit, subjects attended the clinic for Visit 1 assessments. If a subject’s inclusion was confirmed at the time of the screening visit, then the Visit 1 assessments could be performed on the same day as the screening visit. There were three further visits at approximately 3 months, 6 months and 12 months. At the 12 month visit, only lung function and inhalation profiling were assessed.

Center: Universitair Ziekenhuis (UZ) Antwerpen, Pneumologie, Wilrijkstraat 10, Edegem, 2650, Belgium

Indication: Idiopathic Pulmonary Fibrosis

Treatment: No treatment was delivered to the subjects

Objectives:

To characterize the inhalation profiles, airway morphometry and pharyngometry of subjects who had a range of clinical severity of IPF.

To explore the relationship between changes in airway morphometry determined by HRCT and measures of spirometry, diffusion and plethysmography over 6 months.

Primary Endpoints: Inhalation endpoints: Peak pressure Drop, Peak Inspiratory Flow Rate, Inhaled Volume, Inhalation time, Average Inhalation Flow Rate, and Acceleration rate Pharyngometry endpoints: Distance, Volume, and Average cross sectional area. Mouth and throat measurements from HRCT scan reconstruction, including: Length, Minimum cross-sectional area, Average cross-sectional area, Concavity, and Volume. Lung measurements from HRCT scan reconstruction, including: Volume, length, direction and diameter of each airway branch at functional residual capacity (FRC) and total lung capacity (TLC), Lobar volumes at FRC and TLC (including Total region), Relative lobar change from FRC to TLC. Lung function indices by spirometry (forced vital capacity [FVC], forced expiratory volume in one second [FEV1], maximum expiratory flow at 25% and 50% vital capacity [Vmax25 and

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Vmax50, respectively], peak expiratory flow rate [PEFR], peak inspiratory flow rate [PIFR]). Diffusion capacity (diffusing capacity of the lung (DL) for carbon monoxide [DLco], carbon monoxide transfer coefficient [Kco]). Whole body plethysmography including: Volume (TLC, residual volume, FRC), Airway Resistance, Specific Airway Resistance, Airway Conductance, Specific Airway Conductance.

Secondary Endpoints: There were no secondary endpoints in the protocol for this study.

Statistical Methods: This was an exploratory study aiming to characterize the lung function, inhalation profiles, airway morphometry and pharyngometry of subjects with varying clinical severity of IPF. The study endpoints were summarized descriptively, including mean values and two-sided 95% confidence intervals (CIs). No formal hypotheses were tested. No statistical techniques were used to calculate the sample size of 30 subjects, which was based purely on feasibility. Population used for analysis was ‘All Subjects Population’ that comprised of all the subjects who were randomized and completed at least one Visit 1 assessment. This population was used for the evaluation of all data from this study.

Study Population: Male and Non child-bearing potential female subjects with IPF, aged 40 years and over and with body mass index (BMI) within the range 18-32 kilogram (kg)/square meter (m2) (inclusive) at the time of signing the informed consent were included in the study. Two subjects were excluded from the results: Subject 102 who had multiple pulmonary emboli which could confound the pulmonary physiology and Subject 112 who was misdiagnosed and therefore withdrawn from the study as the subject did not have IPF (data from these subjects was included in listings and population summaries).

Total

Number of Subjects:

Planned, N 30

Entered, N 25

Completed, n (% 24 (96)

Total Number Subjects Withdrawn, N (%) 1 (4)

Withdrawn due to Adverse Events n (%) 0

Withdrawn due to Lack of Efficacy n (%) 0

Withdrawn for other reasons n (%) 1 (4)

Demographics Total

N (All Subjects) 25

Females: Males 8:17

Mean Age, years (SD) 71.2 (8.66)

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White - White/Caucasian/European Heritage, n (%) 24 (96)

Primary Endpoint Results:

Inhalation Endpoints

Using Profile with Maximum Peak Pressure

Drop and All Corresponding

Parameters

Parameter: Peak Pressure Drop (kilopascal [kPa])

Parameter: Peak Inspiratory Flow Rate (Litres [L]/minute [min])

Parameter: Inhaled Volume (L)

Instruction/Resistance Visit n Mean (SD) 95% CI n Mean (SD) 95% CI n Mean (SD) 95% CI

Long Steady And Deep/ ~Low

Day 1 22 0.45 (0.35) 0.29, 0.60 22 42.99 (16.95) 35.47, 50.50 22 1.93 (0.83) 1.56, 2.29

Month 3 22 0.50 (0.41) 0.32, 0.68 22 45.90 (17.50) 38.14, 53.66 22 2.01 (0.96) 1.58, 2.43

Month 6 21 0.40 (0.27) 0.28, 0.57 21 41.71 (13.21) 35.70, 47.73 21 1.81 (0.77) 1.46, 2.16

Month 12 10 0.47 (0.46) 0.14, 0.80 10 44.68 (22.17) 28.82, 60.54 10 2.35 (1.36) 1.37, 3.32

Long Steady And Deep/ ~Moderate

Day 1 23 0.61 (0.34) 0.47, 0.76 23 28.08 (7.52) 24.83, 31.33 23 1.89 (0.85) 1.52, 2.25

Month 3 22 0.74 (0.51) 0.52, 0.97 22 30.44 (10.41) 25.83, 35.05 22 2.02 (1.06) 1.55, 2.49

Month 6 23 0.62 (0.43) 0.44, 0.81 23 28.04 (8.98) 24.16, 31.92 23 1.83 (0.82) 1.48, 2.19

Month 12 11 0.64 (0.40) 0.38, 0.91 11 29.23 (9.53) 22.83, 35.64 11 2.10 (1.27) 1.25, 2.96

Long Steady And Deep/ ~High

Day 1 22 1.12 (0.47) 0.91, 1.32 22 20.03 (4.22) 18.15, 21.90 22 2.05 (1.05) 1.58, 2.52

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Month 3 22 1.11 (0.64) 0.83, 1.39 22 19.75 (5.33) 17.39, 22.11 22 2.07 (1.04) 1.61, 2.53

Month 6 23 1.09 (0.74) 0.77, 1.41 23 19.39 (5.88) 16.85, 21.93 23 1.93 (0.99) 1.50, 2.36

Month 12 10 1.03 (0.46) 0.70, 1.36 10 19.38 (4.54) 16.14, 22.63 10 2.42 (1.18) 1.58, 3.26

Maximal Effort/ ~Low Day 1 23 4.03 (1.89) 3.21, 4.85 23 133.77 (36.54) 117.97, 149.57 23 2.11 (1.00) 1.68, 2.54

Month 3 23 4.16 (1.73) 3.41, 4.91 23 137.83 (31.58) 124.18, 151.48 23 2.21 (0.92) 1.82, 2.61

Month 6 23 3.87 (1.56) 3.19, 4.54 23 133.58 (29.18) 120.96, 146.19 23 2.10 (0.90) 1.71, 2.49

Month 12 11 3.43 (1.84) 2.20, 4.67 11 127.79 (39.80) 101.05, 154.53 11 2.29 (1.13) 1.53, 3.05

Maximal Effort/ ~Moderate Day 1 23 5.03 (2.23) 4.06, 5.99 23 81.06 (18.74) 72.96, 89.17 23 1.90 (0.88) 1.52, 2.28

Month 3 23 5.14 (1.96) 4.29, 5.99 23 82.68 (17.01) 75.32, 90.03 23 2.09 (0.86) 1.72, 2.46

Month 6 23 5.15 (2.06) 4.26, 6.04 23 82.44 (19.24) 74.13, 90.76 23 1.96 (0.92) 1.57, 2.36

Month 12 11 4.41 (2.18) 2.95, 5.88 11 76.83 (24.07) 60.66, 93.00 11 2.10 (1.03) 1.40, 2.79

Maximal Effort/ ~High Day 1 23 6.03 (2.54) 4.94, 7.13 23 46.49 (10.43) 41.98, 51.00 23 1.76 (0.81) 1.41, 2.11

Month 3 23 6.20 (2.14) 5.27, 7.13 23 47.57 (8.58) 43.86, 51.28 23 1.85 (0.87) 1.47, 2.22

Month 6 23 6.06 (2.48) 4.98, 7.13 23 46.74 (10.04) 42.39, 51.08 23 1.70 (0.75) 1.38, 2.03

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Month 12 11 4.70 (2.55) 2.99, 6.41 11 40.94 (11.73) 33.06, 48.81 11 2.02 (0.75) 1.51, 2.52

Using Profile with Maximum Peak Pressure

Drop and All Corresponding

Parameters

Parameter: Inhalation Time (second [s]) Parameter: Average Flow Rate (L/min) Parameter: Acceleration Rate (L/min/s)

Instruction/Resistance Visit n Mean (SD) 95% CI n Mean (SD) 95% CI n Mean (SD) 95% CI

Long Steady And Deep/ ~Low

Day 1 22 5.29 (2.55) 4.15, 6.42 22 25.38 (11.15) 20.43, 30.32 20 89.67 (70.87) 56.50, 122.84

Month 3 22 4.71 (2.02) 3.82, 5.61 22 28.38 (14.57) 21.92, 34.84 22 123.40 (103.43) 77.54, 169.25

Month 6 21 4.99 (2.74) 3.74, 6.23 21 25.04 (8.96) 20.96, 29.12 21 94.74 (80.37) 58.16, 131.33

Month 12 10 5.23 (2.70) 3.30, 7.17 10 29.73 (18.58) 16.45, 43.03 9 95.58 (61.95) 47.96, 143.19

Long Steady And Deep/ ~Moderate

Day 1 23 6.68 (2.43) 5.63, 7.74 23 17.92 (6.59) 15.07, 20.76 22 51.59 (42.15) 32.90, 70.28

Month 3 22 6.12 (2.05) 5.21, 7.03 22 20.19 (8.87) 16.26, 24.13 22 68.71 (69.93) 37.70, 99.71

Month 6 23 6.54 (2.77) 5.34, 7.74 23 18.31 (7.16) 15.21, 21.40 22 61.27 (58.37) 35.39, 87.15

Month 12 11 6.56 (2.57) 4.84, 8.29 11 19.76 (9.81) 13.16, 26.35 11 52.69 (46.30) 21.59, 83.79

Long Steady And Deep/ ~High

Day 1 22 8.77 (3.23) 7.33, 10.20 22 14.07 (3.76) 12.41, 15.74 20 33.67 (34.65) 17.45, 49.88

Month 3 22 9.07 (3.10) 7.69, 10.44 22 13.92 (4.97) 11.72, 16.12 21 27.21 (30.06) 13.52, 40.89

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Month 6 23 8.74 (3.46) 7.24, 10.23 23 13.52 (4.43) 11.60, 15.44 20 40.22 (40.03) 21.48, 58.95

Month 12 10 10.07 (2.42) 8.33, 11.80 10 14.10 (4.38) 10.96, 17.23 9 51.05 (40.17) 20.17, 81.92

Maximal Effort/ ~Low Day 1 23 1.56 (0.58) 1.31, 1.81 23 82.59 (23.74) 72.32, 92.86 22 629.00 (298.32) 496.73, 761.26

Month 3 23 1.59 (0.63) 1.31, 1.86 23 86.29 (21.82) 76.86, 95.73 23 594.87 (316.84) 457.86, 731.88

Month 6 23 1.50 (0.55) 1.27, 1.74 23 85.25 (23.45) 75.11, 95.39 23 602.21 (200.14) 515.66, 688.76

Month 12 11 1.60 (0.61) 1.19, 2.01 11 86.29 (29.26) 66.64, 105.95 11 562.89 (266.05) 384.15, 741.62

Maximal Effort/ ~Moderate Day 1 23 2.28 (0.94) 1.88, 2.69 23 50.77 (13.54) 44.92, 56.63 23 313.74 (223.03) 217.30, 410.19

Month 3 23 2.37 (0.83) 2.01, 2.73 23 53.28 (11.50) 48.30, 58.25 23 329.36 (149.32) 264.79, 393.93

Month 6 23 2.19 (0.94) 1.79, 2.60 23 54.05 (15.17) 47.49, 60.61 23 362.70 (189.97) 280.55, 444.85

Month 12 11 2.50 (0.97) 1.84, 3.15 11 50.33 (17.85) 38.34, 62.32 11 323.17 (139.46) 229.48, 416.86

Maximal Effort/ ~High Day 1 23 3.68 (1.78) 2.91, 4.45 23 29.80 (7.95) 26.36, 33.24 23 178.23 (84.53) 141.67, 214.79

Month 3 23 3.59 (1.78) 2.82, 4.35 23 31.38 (5.89) 28.83, 33.92 23 188.01 (82.72) 152.24, 223.78

Month 6 23 3.34 (1.51) 2.69, 3.99 23 31.19 (8.23) 27.63, 34.75 23 178.70 (95.20) 137.53, 219.87

Month 12 11 4.28 (1.32) 3.39, 5.17 11 27.99 (8.09) 22.55, 33.42 11 139.86 (66.09) 95.46, 184.26

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Pharyngometry endpoints

Parameter n Mean (SD) 95% CI

Average Cross Sectional Area (cm2) 23 4.78 (1.17) 4.28, 5.29

Oropharyngeal Volume (cm3) 23 99.30 (22.27) 89.67, 108.93

Distance from Lips to End of Larynx (centimetre [cm]) 23 20.90 (1.64) 20.19, 21.61

Mouth and Throat Measurements from HRCT scan

Endpoint: Mouth and Throat Parameters n Mean (SD) 95% CI

Distance from Lips to End of Larynx (millimetre [mm]) 23 208.27 (17.43) 200.74, 215.81

Average Oropharyngeal Volume (cubic mm [mm3]) 23 55237.05 (21678.56) 45862.54, 64611.56

Average Cross Sectional Area (square mm [mm2) 23 262.81 (95.73) 221.41, 304.21

Minimum Cross Sectional Area (mm2) 23 59.41 (37.57) 43.17, 75.66

Concavity (mm2/ mm2) 23 0.22 (0.13) 0.16, 0.28

Lung measurements from HRCT scan

Parameter: imaging airway volume (iVaw) (mL) Lung volume: FRC Lung volume: TLC

Lung Location Scan Trimmed Pair Visit n Mean (SD) 95% CI n Mean (SD) 95% CI

Right Upper Lobe (RUL)

D1M3 Day 1 23 1.20 (0.78) 0.86, 1.53 23 2.99 (1.33) 2.42, 3.57

Month 3 23 1.16 (0.76) 0.84, 1.49 23 2.99 (1.33) 2.42, 3.57

D1M6 Day 1 23 1.24 (0.83) 0.88, 1.60 23 3.00 (1.43) 2.38, 3.62

Month 6 23 1.24 (0.97) 0.82, 1.65 23 2.99 (1.52) 2.33, 3.64

M3M6 Month 3 23 1.16 (0.74) 0.84, 1.48 23 3.07 (1.44) 2.45, 3.69

Month 6 23 1.17 (0.87) 0.79, 1.54 23 3.06 (1.52) 2.40, 3.72

Left Upper Lobe (LUL) D1M3 Day 1 23 1.09 (0.75) 0.77, 1.42 23 3.08 (1.71) 2.34, 3.82

Month 3 23 1.09 (0.75) 0.76, 1.41 23 3.25 (1.80) 2.48, 4.03

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D1M6 Day 1 23 1.01 (0.77) 0.67, 1.34 23 3.02 (1.62) 2.32, 3.72

Month 6 23 0.96 (0.74) 0.64, 1.28 23 3.00 (1.61) 2.31, 3.70

M3M6 Month 3 23 1.02 (0.79) 0.68, 1.36 23 3.39 (1.86) 2.59, 4.20

Month 6 23 0.98 (0.75) 0.65, 1.30 23 3.23 (1.78) 2.46, 4.00

Right Middle Lobe (RML)

D1M3 Day 1 23 0.45 (0.34) 0.30, 0.60 23 1.60 (0.93) 1.20, 2.00

Month 3 23 0.44 (0.36) 0.29, 0.60 23 1.61 (0.90) 1.23, 2.00

D1M6 Day 1 23 0.44 (0.31) 0.30, 0.57 23 1.62 (0.90) 1.23, 2.01

Month 6 23 0.43 (0.33) 0.29, 0.57 23 1.65 (0.83) 1.29, 2.01

M3M6 Month 3 23 0.43 (0.35) 0.27, 0.58 23 1.62 (0.78) 1.28, 1.95

Month 6 23 0.43 (0.34) 0.28, 0.57 23 1.64 (0.72) 1.33, 1.95

Right Lower Lobe (RLL)

D1M3 Day 1 23 0.86 (0.76) 0.54, 1.19 23 4.10 (2.26) 3.12, 5.08

Month 3 23 0.85 (0.72) 0.54, 1.16 23 4.19 (2.33) 3.18, 5.19

D1M6 Day 1 23 0.86 (0.67) 0.57, 1.16 23 4.09 (2.29) 3.10, 5.08

Month 6 23 0.84 (0.66) 0.56, 1.13 23 3.96 (2.16) 3.03, 4.90

M3M6 Month 3 23 0.86 (0.70) 0.56, 1.17 23 4.10 (1.92) 3.27, 4.93

Month 6 23 0.83 (0.67) 0.54, 1.12 23 3.97 (1.80) 3.19, 4.75

Left Lower Lobe (LLL) D1M3 Day 1 23 1.02 (0.72) 0.71, 1.33 23 4.56 (2.38) 3.53, 5.59

Month 3 23 1.02 (0.76) 0.70, 1.35 23 4.77 (2.44) 3.72, 5.83

D1M6 Day 1 23 1.06 (0.70) 0.75, 1.36 23 4.55 (2.45) 3.49, 5.61

Month 6 23 1.07 (0.89) 0.68, 1.46 23 4.51 (2.19) 3.57, 5.46

M3M6 Month 3 23 1.00 (0.76) 0.68, 1.33 23 4.76 (2.16) 3.83, 5.70

Month 6 23 1.02 (0.87) 0.64, 1.39 23 4.60 (1.95) 3.76, 5.44

Upper Region D1M3 Day 1 23 2.74 (1.72) 2.00, 3.48 23 7.68 (3.72) 6.07, 9.29

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Month 3 23 2.69 (1.74) 1.94, 3.44 23 7.86 (3.76) 6.24, 9.49

D1M6 Day 1 23 2.68 (1.74) 1.93, 3.43 23 7.64 (3.73) 6.03, 9.26

Month 6 23 2.62 (1.83) 1.83, 3.41 23 7.64 (3.72) 6.03, 9.24

M3M6 Month 3 23 2.61 (1.76) 1.85, 3.37 23 8.08 (3.76) 6.46, 9.71

Month 6 23 2.57 (1.81) 1.79, 3.35 23 7.92 (3.72) 6.31, 9.53

Lower Region D1M3 Day 1 23 1.88 (1.40) 1.28, 2.49 23 8.66 (4.47) 6.73, 10.59

Month 3 23 1.88 (1.38) 1.28, 2.48 23 8.96 (4.56) 6.99, 10.93

D1M6 Day 1 23 1.92 (1.31) 1.36, 2.49 23 8.64 (4.55) 6.67, 10.61

Month 6 23 1.91 (1.47) 1.28, 2.55 23 8.47 (4.11) 6.70, 10.25

M3M6 Month 3 23 1.87 (1.35) 1.28, 2.45 23 8.86 (3.87) 7.19, 10.54

Month 6 23 1.84 (1.43) 1.22, 2.46 23 8.57 (3.58) 7.02, 10.12

Central Region D1M3 Day 1 23 28.58 (11.16) 23.75, 33.41 23 49.16 (14.93) 42.71, 55.62

Month 3 23 28.43 (10.76) 23.78, 33.09 23 49.75 (15.04) 43.25, 56.26

D1M6 Day 1 23 28.40 (11.05) 23.62, 33.18 23 49.07 (14.62) 42.75, 55.39

Month 6 23 28.11 (11.56) 23.11, 33.11 23 49.14 (14.63) 42.81, 55.46

M3M6 Month 3 23 27.94 (10.72) 23.30, 32.57 23 49.31 (14.95) 42.85, 55.78

Month 6 23 27.74 (11.38) 22.82, 32.66 23 48.80 (14.82) 42.39, 55.20

Distal Region D1M3 Day 1 23 4.62 (3.01) 3.32, 5.93 23 16.34 (7.71) 13.00, 19.67

Month 3 23 4.57 (3.03) 3.26, 5.88 23 16.82 (7.79) 13.45, 20.19

D1M6 Day 1 23 4.60 (2.94) 3.33, 5.87 23 16.28 (8.01) 12.82, 19.75

Month 6 23 4.54 (3.20) 3.15, 5.92 23 16.11 (7.50) 12.87, 19.35

M3M6 Month 3 23 4.47 (3.01) 3.17, 5.78 23 16.94 (7.19) 13.84, 20.05

Month 6 23 4.41 (3.15) 3.05, 5.77 23 16.49 (6.82) 13.54, 19.44

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Total D1M3 Day 1 23 33.20 (13.41) 27.40, 39.00 23 65.50 (21.25) 56.31, 74.69

Month 3 23 33.00 (13.05) 27.36, 38.64 23 66.57 (21.09) 57.45, 75.69

D1M6 Day 1 23 33.00 (13.30) 27.25, 38.75 23 65.35 (21.39) 56.10, 74.60

Month 6 23 32.64 (14.03) 26.58, 38.71 23 65.25 (20.71) 56.29, 74.20

M3M6 Month 3 23 32.41 (13.03) 26.78, 38.05 23 66.25 (20.81) 57.26, 75.25

Month 6 23 32.15 (13.84) 26.17, 38.14 23 65.29 (20.32) 56.50, 74.07

Parameter: specific imaging airway volume (siVaw) (mL/L) Lung volume: FRC Lung volume: TLC


Right Upper Lobe (RUL)

D1M3 Day 1 23 2.92 (5.91) 0.37, 5.47 23 3.82 (5.34) 1.52, 6.13

Month 3 23 2.67 (4.79) 0.60, 4.74 23 3.96 (5.93) 1.39, 6.52

D1M6 Day 1 23 3.09 (6.67) 0.21, 5.97 23 3.63 (4.36) 1.75, 5.52

Month 6 23 3.01 (6.62) 0.14, 5.87 23 3.79 (4.87) 1.69, 5.89

M3M6 Month 3 23 2.60 (4.41) 0.69, 4.51 23 3.84 (5.09) 1.65, 6.04

Month 6 23 2.68 (5.22) 0.42, 4.94 23 3.91 (5.12) 1.69, 6.12

Left Upper Lobe (LUL) D1M3 Day 1 22 1.44 (0.82) 1.08, 1.81 22 2.62 (1.14) 2.11, 3.12

Month 3 22 1.45 (0.84) 1.08, 1.82 22 2.75 (1.22) 2.21, 3.29

D1M6 Day 1 22 1.30 (0.84) 0.93, 1.67 22 2.55 (1.11) 2.06, 3.04

Month 6 22 1.27 (0.86) 0.89, 1.65 22 2.60 (1.21) 2.06, 3.13

M3M6 Month 3 22 1.35 (0.84) 0.97, 1.72 22 2.86 (1.14) 2.35, 3.36

Month 6 22 1.29 (0.84) 0.91, 1.66 22 2.80 (1.20) 2.26, 3.33

Right Middle Lobe (RML)

D1M3 Day 1 23 1.55 (1.13) 1.05, 2.04 23 3.91 (2.63) 2.78, 5.05

Month 3 23 1.49 (1.19) 0.98, 2.01 23 3.91 (2.57) 2.80, 5.02

D1M6 Day 1 23 1.52 (1.15) 1.02, 2.02 23 3.95 (2.63) 2.81, 5.08

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Month 6 23 1.48 (1.15) 0.98, 1.98 23 4.10 (2.50) 3.02, 5.18

M3M6 Month 3 23 1.49 (1.30) 0.93, 2.06 23 3.89 (2.23) 2.93, 4.86

Month 6 23 1.50 (1.21) 0.98, 2.03 23 4.07 (2.21) 3.11, 5.02

Right Lower Lobe (RLL)

D1M3 Day 1 23 1.82 (1.48) 1.18, 2.47 23 4.44 (2.29) 3.44, 5.43

Month 3 23 1.76 (1.39) 1.16, 2.36 23 4.57 (2.47) 3.50, 5.63

D1M6 Day 1 23 1.89 (1.49) 1.24, 2.53 23 4.40 (2.23) 3.43, 5.36

Month 6 23 1.76 (1.36) 1.17, 2.35 23 4.40 (2.15) 3.47, 5.33

M3M6 Month 3 23 1.79 (1.39) 1.19, 2.39 23 4.50 (1.90) 3.68, 5.33

Month 6 23 1.68 (1.28) 1.13, 2.23 23 4.53 (1.97) 3.68, 5.38

Left Lower Lobe (LLL) D1M3 Day 1 22 2.03 (1.82) 1.22, 2.83 22 4.62 (2.45) 3.54, 5.71

Month 3 22 2.04 (1.82) 1.23, 2.84 22 4.87 (2.69) 3.67, 6.06

D1M6 Day 1 22 2.08 (1.77) 1.29, 2.86 22 4.63 (2.50) 3.52, 5.74

Month 6 22 2.03 (1.81) 1.22, 2.83 22 4.81 (2.46) 3.72, 5.90

M3M6 Month 3 22 1.99 (1.85) 1.17, 2.81 22 4.92 (2.38) 3.87, 5.97

Month 6 22 1.93 (1.82) 1.12, 2.73 22 4.95 (2.25) 3.95, 5.94


Month 3 22 1.51 (0.88) 1.12, 1.90 22 2.86 (1.19) 2.34, 3.39

D1M6 Day 1 22 1.47 (0.82) 1.10, 1.83 22 2.78 (1.15) 2.27, 3.29

Month 6 22 1.42 (0.84) 1.05, 1.79 22 2.83 (1.22) 2.29, 3.37

M3M6 Month 3 22 1.47 (0.89) 1.08, 1.87 22 2.93 (1.07) 2.46, 3.41

Month 6 22 1.41 (0.83) 1.04, 1.78 22 2.95 (1.20) 2.42, 3.48


Month 3 22 1.85 (1.57) 1.16, 2.55 22 4.70 (2.52) 3.58, 5.82

12

D1M6 Day 1 22 1.95 (1.62) 1.23, 2.67 22 4.51 (2.30) 3.49, 5.53

Month 6 22 1.86 (1.57) 1.17, 2.56 22 4.62 (2.19) 3.65, 5.59

M3M6 Month 3 22 1.85 (1.58) 1.15, 2.55 22 4.71 (2.08) 3.79, 5.63

Month 6 22 1.77 (1.51) 1.09, 2.44 22 4.74 (2.02) 3.85, 5.64


Month 3 23 10.86 (3.82) 9.20, 12.51 23 11.00 (3.31) 9.57, 12.43

D1M6 Day 1 23 10.72 (3.69) 9.12, 12.32 23 10.94 (3.26) 9.53, 12.35

Month 6 23 10.76 (3.90) 9.07, 12.44 23 11.12 (3.38) 9.66, 12.59

M3M6 Month 3 23 10.61 (3.66) 9.03, 12.20 23 10.90 (3.29) 9.48, 12.32

Month 6 23 10.57 (3.71) 8.96, 12.18 23 11.03 (3.36) 9.57, 12.48


Month 3 23 1.70 (1.12) 1.22, 2.19 23 3.65 (1.62) 2.95, 4.35

D1M6 Day 1 23 1.73 (1.13) 1.23, 2.22 23 3.49 (1.51) 2.84, 4.15

Month 6 23 1.65 (1.11) 1.17, 2.13 23 3.56 (1.51) 2.91, 4.22

M3M6 Month 3 23 1.67 (1.12) 1.19, 2.15 23 3.66 (1.35) 3.08, 4.24

Month 6 23 1.60 (1.06) 1.14, 2.06 23 3.67 (1.40) 3.06, 4.27

Total D1M3 Day 1 23 12.50 (4.35) 10.63, 14.38 23 14.47 (4.34) 12.59, 16.34

Month 3 23 12.56 (4.52) 10.60, 14.51 23 14.65 (4.47) 12.72, 16.59

D1M6 Day 1 23 12.44 (4.38) 10.55, 14.34 23 14.43 (4.34) 12.55, 16.31

Month 6 23 12.41 (4.53) 10.45, 14.37 23 14.69 (4.47) 12.75, 16.62

M3M6 Month 3 23 12.28 (4.41) 10.38, 14.19 23 14.56 (4.32) 12.69, 16.43

Month 6 23 12.17 (4.33) 10.30, 14.04 23 14.70 (4.44) 12.78, 16.62

Parameter: imaging airway resistance (iRaw) (kPa*s/L) Lung volume: FRC Lung volume: TLC

13


RUL D1M3 Day 1 23 0.21 (0.16) 0.13, 0.28 23 0.09 (0.10) 0.05, 0.14

Month 3 23 0.27 (0.34) 0.12, 0.42 23 0.09 (0.10) 0.05, 0.13

D1M6 Day 1 23 0.20 (0.14) 0.14, 0.26 23 0.09 (0.09) 0.05, 0.13

Month 6 23 0.46 (0.63) 0.19, 0.73 23 0.10 (0.12) 0.05, 0.15

M3M6 Month 3 23 0.26 (0.31) 0.13, 0.39 23 0.09 (0.09) 0.05, 0.13

Month 6 23 0.43 (0.64) 0.15, 0.71 23 0.10 (0.12) 0.05, 0.15

LUL D1M3 Day 1 23 0.18 (0.17) 0.10, 0.25 23 0.07 (0.05) 0.05, 0.09

Month 3 23 0.15 (0.12) 0.09, 0.20 23 0.06 (0.05) 0.03, 0.08

D1M6 Day 1 23 0.15 (0.16) 0.08, 0.23 23 0.07 (0.08) 0.04, 0.10

Month 6 23 0.20 (0.18) 0.12, 0.28 23 0.08 (0.12) 0.03, 0.13

M3M6 Month 3 23 0.13 (0.13) 0.07, 0.18 23 0.05 (0.06) 0.03, 0.08

Month 6 23 0.21 (0.26) 0.10, 0.32 23 0.07 (0.09) 0.04, 0.11

RML D1M3 Day 1 23 0.31 (0.44) 0.12, 0.50 23 0.18 (0.24) 0.07, 0.28

Month 3 23 0.36 (0.36) 0.21, 0.52 23 0.21 (0.43) 0.02, 0.39

D1M6 Day 1 23 0.50 (1.10) 0.02, 0.97 23 0.21 (0.36) 0.06, 0.37

Month 6 23 1.09 (2.56) -0.02, 2.20 23 0.18 (0.32) 0.05, 0.32

M3M6 Month 3 23 0.21 (0.16) 0.14, 0.28 23 0.20 (0.38) 0.03, 0.36

Month 6 23 0.29 (0.28) 0.17, 0.42 23 0.16 (0.20) 0.07, 0.25

RLL D1M3 Day 1 23 0.12 (0.14) 0.06, 0.18 23 0.04 (0.05) 0.02, 0.07

Month 3 23 0.12 (0.10) 0.08, 0.16 23 0.04 (0.06) 0.02, 0.07

D1M6 Day 1 23 0.11 (0.10) 0.07, 0.16 23 0.04 (0.04) 0.02, 0.05

Month 6 23 0.11 (0.12) 0.06, 0.16 23 0.04 (0.06) 0.02, 0.07

14

M3M6 Month 3 23 0.11 (0.11) 0.06, 0.15 23 0.04 (0.04) 0.02, 0.06

Month 6 23 0.14 (0.15) 0.07, 0.21 23 0.04 (0.05) 0.02, 0.06

LLL D1M3 Day 1 23 0.13 (0.09) 0.09, 0.17 23 0.05 (0.04) 0.03, 0.06

Month 3 23 0.23 (0.42) 0.05, 0.41 23 0.05 (0.07) 0.02, 0.08

D1M6 Day 1 23 0.13 (0.19) 0.05, 0.22 23 0.05 (0.05) 0.02, 0.07

Month 6 23 0.17 (0.18) 0.09, 0.25 23 0.04 (0.07) 0.01, 0.07

M3M6 Month 3 23 0.11 (0.09) 0.07, 0.15 23 0.04 (0.04) 0.02, 0.06

Month 6 23 0.17 (0.20) 0.08, 0.26 23 0.04 (0.03) 0.02, 0.05


Month 3 23 0.05 (0.04) 0.03, 0.07 23 0.03 (0.03) 0.01, 0.04

D1M6 Day 1 23 0.05 (0.05) 0.03, 0.08 23 0.03 (0.03) 0.01, 0.04

Month 6 23 0.08 (0.07) 0.05, 0.11 23 0.03 (0.05) 0.01, 0.05

M3M6 Month 3 23 0.04 (0.04) 0.02, 0.06 23 0.03 (0.03) 0.01, 0.04

Month 6 23 0.07 (0.08) 0.04, 0.11 23 0.03 (0.04) 0.01, 0.05


Month 3 23 0.06 (0.07) 0.03, 0.09 23 0.02 (0.03) 0.01, 0.04

D1M6 Day 1 23 0.04 (0.03) 0.03, 0.06 23 0.02 (0.02) 0.01, 0.03

Month 6 23 0.05 (0.04) 0.03, 0.06 23 0.02 (0.03) 0.01, 0.03

M3M6 Month 3 23 0.04 (0.02) 0.03, 0.05 23 0.02 (0.02) 0.01, 0.03

Month 6 23 0.06 (0.05) 0.04, 0.08 23 0.02 (0.01) 0.01, 0.02


Month 3 23 0.04 (0.07) 0.01, 0.07 23 0.01 (0.01) 0.01, 0.02

D1M6 Day 1 23 0.03 (0.03) 0.02, 0.04 23 0.01 (0.01) 0.01, 0.02

15

Month 6 23 0.04 (0.08) 0.01, 0.08 23 0.01 (0.01) 0.01, 0.02

M3M6 Month 3 23 0.04 (0.06) 0.01, 0.07 23 0.01 (0.01) 0.01, 0.02

Month 6 23 0.04 (0.08) 0.01, 0.08 23 0.01 (0.01) 0.01, 0.02


Month 3 23 0.02 (0.02) 0.01, 0.03 23 0.01 (0.01) 0.01, 0.02

D1M6 Day 1 23 0.02 (0.02) 0.02, 0.03 23 0.01 (0.01) 0.01, 0.02

Month 6 23 0.03 (0.02) 0.02, 0.03 23 0.01 (0.02) 0.00, 0.02

M3M6 Month 3 23 0.02 (0.01) 0.01, 0.02 23 0.01 (0.01) 0.01, 0.02

Month 6 23 0.03 (0.02) 0.02, 0.04 23 0.01 (0.01) 0.01, 0.02

Total D1M3 Day 1 23 0.05 (0.04) 0.04, 0.07 23 0.03 (0.02) 0.02, 0.03

Month 3 23 0.06 (0.07) 0.03, 0.09 23 0.02 (0.02) 0.02, 0.03

D1M6 Day 1 23 0.05 (0.04) 0.03, 0.07 23 0.02 (0.02) 0.02, 0.03

Month 6 23 0.07 (0.09) 0.03, 0.11 23 0.03 (0.02) 0.02, 0.04

M3M6 Month 3 23 0.06 (0.06) 0.03, 0.09 23 0.02 (0.02) 0.02, 0.03

Month 6 23 0.07 (0.09) 0.03, 0.11 23 0.02 (0.01) 0.02, 0.03

Parameter: specific imaging airway resistance (siRaw) (kPa*s)

Lung volume: FRC Lung volume: TLC


RUL D1M3 Day 1 23 0.14 (0.11) 0.09, 0.18 23 0.10 (0.10) 0.06, 0.14

Month 3 23 0.17 (0.20) 0.08, 0.25 23 0.10 (0.10) 0.05, 0.14

D1M6 Day 1 23 0.14 (0.10) 0.09, 0.18 23 0.09 (0.09) 0.05, 0.13

Month 6 23 0.26 (0.30) 0.13, 0.38 23 0.10 (0.11) 0.05, 0.15

M3M6 Month 3 23 0.16 (0.18) 0.08, 0.24 23 0.10 (0.11) 0.05, 0.15

16

Month 6 23 0.24 (0.34) 0.10, 0.39 23 0.11 (0.12) 0.05, 0.16

LUL D1M3 Day 1 22 0.12 (0.09) 0.08, 0.16 22 0.08 (0.05) 0.06, 0.10

Month 3 22 0.10 (0.08) 0.07, 0.14 22 0.06 (0.06) 0.04, 0.09

D1M6 Day 1 22 0.11 (0.08) 0.07, 0.14 22 0.08 (0.08) 0.04, 0.11

Month 6 22 0.14 (0.11) 0.09, 0.19 22 0.09 (0.12) 0.03, 0.14

M3M6 Month 3 22 0.09 (0.09) 0.05, 0.13 22 0.06 (0.06) 0.04, 0.09

Month 6 22 0.13 (0.16) 0.06, 0.20 22 0.09 (0.09) 0.04, 0.13

RML D1M3 Day 1 23 0.09 (0.11) 0.04, 0.14 23 0.08 (0.13) 0.02, 0.14

Month 3 23 0.11 (0.12) 0.06, 0.16 23 0.11 (0.26) 0.00, 0.22

D1M6 Day 1 23 0.16 (0.44) -0.03, 0.35 23 0.11 (0.21) 0.01, 0.20

Month 6 23 0.35 (0.92) -0.05, 0.75 23 0.10 (0.20) 0.01, 0.18

M3M6 Month 3 23 0.07 (0.06) 0.04, 0.09 23 0.11 (0.23) 0.01, 0.21

Month 6 23 0.08 (0.07) 0.05, 0.11 23 0.08 (0.13) 0.03, 0.13

RLL D1M3 Day 1 23 0.07 (0.10) 0.03, 0.11 23 0.04 (0.06) 0.01, 0.07

Month 3 23 0.06 (0.06) 0.04, 0.09 23 0.04 (0.06) 0.02, 0.07

D1M6 Day 1 23 0.06 (0.05) 0.03, 0.08 23 0.04 (0.04) 0.02, 0.05

Month 6 23 0.06 (0.06) 0.03, 0.08 23 0.04 (0.06) 0.02, 0.07

M3M6 Month 3 23 0.05 (0.05) 0.03, 0.07 23 0.04 (0.05) 0.02, 0.06

Month 6 23 0.07 (0.09) 0.04, 0.11 23 0.04 (0.05) 0.01, 0.06

LLL D1M3 Day 1 22 0.07 (0.05) 0.05, 0.10 22 0.05 (0.04) 0.03, 0.06

Month 3 22 0.13 (0.26) 0.01, 0.24 22 0.05 (0.07) 0.02, 0.08

D1M6 Day 1 22 0.08 (0.13) 0.02, 0.14 22 0.04 (0.04) 0.02, 0.06

Month 6 22 0.09 (0.09) 0.05, 0.13 22 0.04 (0.06) 0.01, 0.07

17

M3M6 Month 3 22 0.06 (0.05) 0.04, 0.08 22 0.04 (0.04) 0.02, 0.06

Month 6 22 0.09 (0.11) 0.04, 0.14 22 0.04 (0.03) 0.02, 0.05


Month 3 22 0.09 (0.06) 0.06, 0.11 22 0.07 (0.08) 0.04, 0.11

D1M6 Day 1 22 0.09 (0.06) 0.06, 0.12 22 0.08 (0.09) 0.04, 0.12

Month 6 22 0.13 (0.10) 0.08, 0.17 22 0.09 (0.12) 0.03, 0.14

M3M6 Month 3 22 0.07 (0.06) 0.04, 0.10 22 0.07 (0.08) 0.04, 0.11

Month 6 22 0.11 (0.10) 0.06, 0.15 22 0.09 (0.11) 0.04, 0.13


Month 3 22 0.07 (0.09) 0.03, 0.11 22 0.04 (0.06) 0.02, 0.07

D1M6 Day 1 22 0.05 (0.04) 0.03, 0.06 22 0.04 (0.04) 0.02, 0.06

Month 6 22 0.05 (0.04) 0.03, 0.07 22 0.04 (0.06) 0.01, 0.07

M3M6 Month 3 22 0.04 (0.02) 0.03, 0.05 22 0.04 (0.04) 0.02, 0.06

Month 6 22 0.06 (0.06) 0.04, 0.09 22 0.03 (0.03) 0.02, 0.05


Month 3 23 0.09 (0.12) 0.04, 0.14 23 0.05 (0.03) 0.04, 0.06

D1M6 Day 1 23 0.07 (0.06) 0.05, 0.09 23 0.06 (0.03) 0.04, 0.07

Month 6 23 0.11 (0.21) 0.02, 0.20 23 0.05 (0.03) 0.04, 0.07

M3M6 Month 3 23 0.09 (0.11) 0.04, 0.13 23 0.05 (0.03) 0.04, 0.07

Month 6 23 0.11 (0.21) 0.02, 0.20 23 0.05 (0.03) 0.04, 0.06


Month 3 23 0.06 (0.05) 0.04, 0.08 23 0.05 (0.07) 0.02, 0.08

D1M6 Day 1 23 0.06 (0.04) 0.04, 0.07 23 0.05 (0.05) 0.03, 0.07

18

Month 6 23 0.07 (0.05) 0.04, 0.09 23 0.06 (0.08) 0.02, 0.09

M3M6 Month 3 23 0.05 (0.03) 0.03, 0.06 23 0.05 (0.06) 0.02, 0.07

Month 6 23 0.07 (0.06) 0.04, 0.09 23 0.05 (0.05) 0.03, 0.07

Total D1M3 Day 1 23 0.13 (0.09) 0.10, 0.17 23 0.11 (0.06) 0.08, 0.13

Month 3 23 0.15 (0.12) 0.10, 0.20 23 0.10 (0.08) 0.07, 0.14

D1M6 Day 1 23 0.13 (0.08) 0.09, 0.16 23 0.10 (0.07) 0.08, 0.13

Month 6 23 0.18 (0.24) 0.07, 0.28 23 0.11 (0.10) 0.07, 0.15

M3M6 Month 3 23 0.13 (0.11) 0.08, 0.18 23 0.10 (0.07) 0.07, 0.13

Month 6 23 0.18 (0.25) 0.07, 0.28 23 0.10 (0.06) 0.07, 0.12

Note: iVaww and siVaww are only measured at the TLC lung volume

Parameter: imaging airway wall thickness (iVaww) (mL)

Parameter: specific imaging airway wall thickness (siVaww) (mL/L)


RUL D1M3 Day 1 23 9.11 (3.36) 7.66, 10.57 23 10.65 (9.69) 6.46, 14.83

Month 3 23 9.11 (3.40) 7.64, 10.58 23 10.86 (10.40) 6.36, 15.36

D1M6 Day 1 23 9.13 (3.64) 7.55, 10.71 23 10.39 (8.41) 6.75, 14.03

Month 6 23 9.49 (4.15) 7.69, 11.28 23 11.81 (12.67) 6.34, 17.29

M3M6 Month 3 23 9.27 (3.71) 7.67, 10.88 23 10.89 (10.06) 6.54, 15.24

Month 6 23 9.68 (4.22) 7.85, 11.50 23 12.24 (14.05) 6.17, 18.32

LUL D1M3 Day 1 23 11.22 (5.19) 8.97, 13.46 22 9.93 (3.83) 8.24, 11.63

Month 3 23 11.48 (5.57) 9.07, 13.89 22 10.18 (4.38) 8.24, 12.13

D1M6 Day 1 23 11.00 (4.93) 8.87, 13.13 22 9.75 (3.80) 8.07, 11.44

Month 6 23 11.32 (5.23) 9.06, 13.58 22 10.15 (4.35) 8.22, 12.08

M3M6 Month 3 23 11.79 (5.43) 9.44, 14.14 22 10.43 (4.06) 8.63, 12.23

19

Month 6 23 11.89 (5.47) 9.53, 14.26 22 10.67 (4.25) 8.78, 12.55

RML D1M3 Day 1 23 5.52 (2.56) 4.41, 6.63 23 13.53 (7.01) 10.50, 16.56

Month 3 23 5.54 (2.63) 4.40, 6.68 23 13.54 (7.38) 10.35, 16.73

D1M6 Day 1 23 5.58 (2.49) 4.50, 6.65 23 13.62 (7.25) 10.48, 16.75

Month 6 23 5.79 (2.56) 4.68, 6.89 23 14.41 (7.73) 11.07, 17.75

M3M6 Month 3 23 5.47 (2.02) 4.59, 6.34 23 13.32 (6.30) 10.60, 16.05

Month 6 23 5.70 (2.10) 4.80, 6.61 23 14.21 (6.49) 11.40, 17.01

RLL D1M3 Day 1 23 14.09 (5.11) 11.88, 16.29 23 15.94 (6.98) 12.92, 18.95

Month 3 23 14.18 (5.48) 11.81, 16.55 23 15.96 (6.78) 13.03, 18.89

D1M6 Day 1 23 14.15 (5.71) 11.68, 16.62 23 15.92 (6.90) 12.93, 18.90

Month 6 23 14.39 (5.90) 11.84, 16.94 23 16.57 (7.31) 13.41, 19.73

M3M6 Month 3 23 13.81 (4.25) 11.97, 15.64 23 15.67 (5.35) 13.36, 17.98

Month 6 23 14.10 (4.19) 12.29, 15.91 23 16.62 (6.53) 13.80, 19.45

LLL D1M3 Day 1 23 15.29 (5.18) 13.05, 17.53 22 16.16 (6.17) 13.42, 18.89

Month 3 23 15.57 (5.27) 13.29, 17.85 22 16.66 (6.98) 13.56, 19.75

D1M6 Day 1 23 15.40 (5.77) 12.91, 17.90 22 16.43 (6.79) 13.42, 19.44

Month 6 23 15.91 (5.63) 13.47, 18.34 22 17.59 (8.20) 13.95, 21.23

M3M6 Month 3 23 15.46 (4.55) 13.49, 17.42 22 16.75 (6.50) 13.87, 19.63

Month 6 23 15.80 (4.49) 13.86, 17.74 22 17.55 (7.48) 14.23, 20.86


Month 3 23 26.13 (11.18) 21.30, 30.97 22 9.88 (3.78) 8.21, 11.56

D1M6 Day 1 23 25.71 (10.63) 21.11, 30.30 22 9.67 (3.40) 8.16, 11.18

Month 6 23 26.59 (11.44) 21.65, 31.54 22 10.08 (3.88) 8.36, 11.80

20

M3M6 Month 3 23 26.53 (10.63) 21.93, 31.13 22 10.01 (3.41) 8.50, 11.52

Month 6 23 27.27 (11.27) 22.40, 32.15 22 10.40 (3.89) 8.68, 12.13


Month 3 23 29.75 (10.29) 25.30, 34.20 22 16.29 (6.49) 13.42, 19.17

D1M6 Day 1 23 29.55 (10.97) 24.81, 34.30 22 16.18 (6.26) 13.41, 18.96

Month 6 23 30.29 (10.88) 25.59, 35.00 22 17.08 (7.36) 13.82, 20.34

M3M6 Month 3 23 29.26 (8.33) 25.66, 32.86 22 16.21 (5.53) 13.76, 18.66

Month 6 23 29.90 (8.09) 26.40, 33.39 22 17.03 (6.63) 14.09, 19.97

Central Region D1M3 Day 1 23 30.42 (7.63) 27.12, 33.72

23 6.79 (1.71) 6.05, 7.52

Month 3 23 30.70 (6.97) 27.68, 33.71 23 6.87 (1.81) 6.09, 7.65

D1M6 Day 1 23 30.38 (7.41) 27.18, 33.58 23 6.79 (1.71) 6.05, 7.53

Month 6 23 31.02 (7.46) 27.79, 34.24 23 7.11 (2.10) 6.20, 8.02

M3M6 Month 3 23 30.54 (7.04) 27.49, 33.58 23 6.83 (1.80) 6.05, 7.61

Month 6 23 30.87 (7.67) 27.56, 34.19 23 7.06 (2.10) 6.15, 7.97


Month 3 23 55.88 (19.93) 47.26, 64.50 23 12.40 (4.50) 10.45, 14.34

D1M6 Day 1 23 55.26 (21.03) 46.17, 64.36 23 12.12 (4.16) 10.32, 13.92

Month 6 23 56.88 (21.58) 47.55, 66.22 23 12.85 (4.81) 10.77, 14.93

M3M6 Month 3 23 55.79 (17.80) 48.09, 63.49 23 12.37 (3.89) 10.69, 14.05

Month 6 23 57.17 (18.27) 49.27, 65.07 23 13.02 (4.47) 11.09, 14.95

Total D1M3 Day 1 23 85.64 (25.58) 74.58, 96.70 23 18.96 (5.39) 16.63, 21.29

Month 3 23 86.58 (25.45) 75.57, 97.59 23 19.27 (5.88) 16.73, 21.81

21

D1M6 Day 1 23 85.64 (27.06) 73.94, 97.34 23 18.91 (5.39) 16.58, 21.24

Month 6 23 87.90 (27.41) 76.05, 99.75 23 19.96 (6.40) 17.19, 22.73

M3M6 Month 3 23 86.33 (23.86) 76.01, 96.64 23 19.20 (5.42) 16.85, 21.54

Month 6 23 88.04 (24.82) 77.31, 98.77 23 20.08 (6.30) 17.36, 22.80

Parameter: imaging airway surface area (iSaw) (mm^2) Lung volume: FRC Lung volume: TLC


RUL D1M3 Day 1 23 1.63 (0.93) 1.22, 2.03 23 3.65 (1.42) 3.03, 4.26

Month 3 23 1.60 (0.94) 1.20, 2.01 23 3.62 (1.36) 3.03, 4.21

D1M6 Day 1 23 1.69 (1.07) 1.23, 2.15 23 3.65 (1.54) 2.98, 4.32

Month 6 23 1.70 (1.16) 1.19, 2.20 23 3.63 (1.57) 2.95, 4.31

M3M6 Month 3 23 1.57 (0.94) 1.17, 1.98 23 3.71 (1.52) 3.05, 4.37

Month 6 23 1.58 (1.00) 1.14, 2.01 23 3.72 (1.60) 3.03, 4.41

LUL D1M3 Day 1 23 1.60 (0.96) 1.19, 2.02 23 3.90 (2.01) 3.04, 4.77

Month 3 23 1.59 (0.99) 1.16, 2.01 23 4.00 (2.02) 3.13, 4.87

D1M6 Day 1 23 1.46 (1.01) 1.02, 1.90 23 3.77 (1.82) 2.99, 4.56

Month 6 23 1.43 (1.00) 1.00, 1.86 23 3.77 (1.83) 2.98, 4.56

M3M6 Month 3 23 1.45 (1.05) 1.00, 1.91 23 4.21 (2.11) 3.30, 5.12

Month 6 23 1.43 (1.02) 0.99, 1.87 23 4.11 (2.07) 3.21, 5.00

RML D1M3 Day 1 23 0.69 (0.51) 0.47, 0.91 23 2.04 (1.04) 1.59, 2.50

Month 3 23 0.68 (0.53) 0.45, 0.90 23 2.04 (0.99) 1.61, 2.47

D1M6 Day 1 23 0.66 (0.45) 0.46, 0.85 23 2.08 (1.00) 1.65, 2.51

Month 6 23 0.65 (0.47) 0.45, 0.85 23 2.09 (0.94) 1.68, 2.50

M3M6 Month 3 23 0.64 (0.50) 0.43, 0.86 23 2.02 (0.81) 1.67, 2.37

22

Month 6 23 0.64 (0.48) 0.43, 0.85 23 2.05 (0.76) 1.72, 2.38

RLL D1M3 Day 1 23 1.35 (1.10) 0.87, 1.82 23 4.88 (2.40) 3.84, 5.91

Month 3 23 1.33 (1.06) 0.87, 1.78 23 4.90 (2.38) 3.88, 5.93

D1M6 Day 1 23 1.33 (0.95) 0.92, 1.74 23 4.84 (2.49) 3.76, 5.92

Month 6 23 1.31 (0.93) 0.90, 1.71 23 4.75 (2.44) 3.70, 5.81

M3M6 Month 3 23 1.32 (0.99) 0.89, 1.75 23 4.74 (1.96) 3.89, 5.59

Month 6 23 1.29 (0.95) 0.88, 1.70 23 4.70 (1.98) 3.84, 5.56

LLL D1M3 Day 1 23 1.49 (0.97) 1.07, 1.91 23 5.17 (2.37) 4.15, 6.20

Month 3 23 1.47 (0.99) 1.04, 1.90 23 5.26 (2.32) 4.26, 6.27

D1M6 Day 1 23 1.48 (0.90) 1.10, 1.87 23 5.17 (2.45) 4.11, 6.23

Month 6 23 1.49 (1.03) 1.04, 1.94 23 5.15 (2.27) 4.16, 6.13

M3M6 Month 3 23 1.40 (0.94) 0.99, 1.81 23 5.26 (2.07) 4.37, 6.16

Month 6 23 1.40 (0.96) 0.98, 1.82 23 5.19 (1.98) 4.33, 6.04


Month 3 23 3.86 (2.29) 2.87, 4.85 23 9.66 (4.09) 7.89, 11.43

D1M6 Day 1 23 3.81 (2.30) 2.82, 4.80 23 9.50 (4.13) 7.72, 11.29

Month 6 23 3.77 (2.40) 2.73, 4.81 23 9.49 (4.10) 7.72, 11.26

M3M6 Month 3 23 3.67 (2.32) 2.67, 4.67 23 9.94 (4.12) 8.16, 11.72

Month 6 23 3.65 (2.32) 2.64, 4.65 23 9.87 (4.12) 8.09, 11.65


Month 3 23 2.79 (1.95) 1.95, 3.64 23 10.17 (4.48) 8.23, 12.10

D1M6 Day 1 23 2.81 (1.77) 2.05, 3.57 23 10.01 (4.72) 7.97, 12.05

Month 6 23 2.79 (1.87) 1.98, 3.60 23 9.90 (4.46) 7.97, 11.83

23

M3M6 Month 3 23 2.72 (1.82) 1.93, 3.51 23 10.00 (3.82) 8.35, 11.66

Month 6 23 2.68 (1.78) 1.92, 3.45 23 9.89 (3.78) 8.25, 11.52


Month 3 23 10.71 (2.60) 9.59, 11.83 23 14.77 (2.98) 13.49, 16.06

D1M6 Day 1 23 10.71 (2.50) 9.63, 11.80 23 14.68 (2.88) 13.43, 15.92

Month 6 23 10.66 (2.52) 9.57, 11.75 23 14.69 (2.88) 13.45, 15.94

M3M6 Month 3 23 10.51 (2.56) 9.41, 11.62 23 14.63 (2.92) 13.37, 15.90

Month 6 23 10.50 (2.51) 9.41, 11.58 23 14.56 (2.89) 13.31, 15.81


Month 3 23 6.66 (4.10) 4.88, 8.43 23 19.82 (7.83) 16.44, 23.21

D1M6 Day 1 23 6.62 (3.93) 4.92, 8.32 23 19.51 (8.52) 15.83, 23.20

Month 6 23 6.57 (4.15) 4.77, 8.36 23 19.39 (8.21) 15.84, 22.94

M3M6 Month 3 23 6.39 (3.99) 4.66, 8.11 23 19.94 (7.31) 16.78, 23.10

Month 6 23 6.33 (3.97) 4.61, 8.05 23 19.76 (7.23) 16.63, 22.88

Total D1M3 Day 1 23 17.55 (6.08) 14.92, 20.18 23 34.34 (10.47) 29.81, 38.87

Month 3 23 17.37 (6.19) 14.69, 20.04 23 34.60 (10.11) 30.23, 38.97

D1M6 Day 1 23 17.33 (5.99) 14.74, 19.92 23 34.19 (10.85) 29.49, 38.88

Month 6 23 17.22 (6.18) 14.55, 19.89 23 34.08 (10.44) 29.57, 38.60

M3M6 Month 3 23 16.90 (6.10) 14.26, 19.54 23 34.58 (9.64) 30.40, 38.75

Month 6 23 16.83 (6.02) 14.23, 19.43 23 34.32 (9.51) 30.21, 38.43

Parameter: specific imaging airway surface area (siSaw) (mm^2/L)

Lung volume: FRC Lung volume: TLC


24

RUL D1M3 Day 1 23 3.66 (6.34) 0.92, 6.40 23 4.36 (4.74) 2.31, 6.41

Month 3 23 3.42 (5.26) 1.15, 5.70 23 4.38 (4.92) 2.26, 6.51

D1M6 Day 1 23 3.89 (7.33) 0.71, 7.06 23 4.15 (3.73) 2.54, 5.76

Month 6 23 3.80 (7.08) 0.74, 6.86 23 4.31 (4.16) 2.51, 6.11

M3M6 Month 3 23 3.33 (4.96) 1.19, 5.48 23 4.34 (4.42) 2.43, 6.25

Month 6 23 3.39 (5.53) 1.00, 5.78 23 4.46 (4.56) 2.49, 6.44

LUL D1M3 Day 1 22 2.18 (1.19) 1.65, 2.71 22 3.37 (1.35) 2.77, 3.97

Month 3 22 2.17 (1.18) 1.64, 2.69 22 3.43 (1.36) 2.83, 4.03

D1M6 Day 1 22 1.95 (1.21) 1.41, 2.49 22 3.25 (1.28) 2.68, 3.82

Month 6 22 1.95 (1.25) 1.39, 2.50 22 3.31 (1.40) 2.69, 3.93

M3M6 Month 3 22 1.95 (1.19) 1.42, 2.47 22 3.57 (1.24) 3.02, 4.12

Month 6 22 1.93 (1.24) 1.38, 2.49 22 3.58 (1.34) 2.99, 4.17

RML D1M3 Day 1 23 2.36 (1.62) 1.66, 3.06 23 5.00 (2.93) 3.74, 6.27

Month 3 23 2.28 (1.62) 1.58, 2.98 23 4.93 (2.80) 3.72, 6.14

D1M6 Day 1 23 2.29 (1.58) 1.60, 2.97 23 5.06 (3.00) 3.77, 6.36

Month 6 23 2.28 (1.64) 1.57, 2.99 23 5.15 (2.82) 3.93, 6.37

M3M6 Month 3 23 2.24 (1.76) 1.48, 3.01 23 4.84 (2.35) 3.83, 5.86

Month 6 23 2.29 (1.71) 1.55, 3.03 23 5.04 (2.31) 4.04, 6.03

RLL D1M3 Day 1 23 2.83 (2.00) 1.97, 3.70 23 5.29 (2.32) 4.29, 6.29

Month 3 23 2.72 (1.91) 1.89, 3.54 23 5.34 (2.35) 4.32, 6.35

D1M6 Day 1 23 2.90 (2.00) 2.03, 3.76 23 5.21 (2.26) 4.23, 6.19

Month 6 23 2.72 (1.86) 1.92, 3.53 23 5.27 (2.28) 4.28, 6.25

M3M6 Month 3 23 2.75 (1.90) 1.93, 3.57 23 5.22 (1.82) 4.43, 6.01

25

Month 6 23 2.62 (1.71) 1.89, 3.36 23 5.35 (2.01) 4.48, 6.22

LLL D1M3 Day 1 22 2.93 (2.26) 1.93, 3.94 22 5.23 (2.15) 4.28, 6.19

Month 3 22 2.92 (2.31) 1.89, 3.94 22 5.34 (2.19) 4.37, 6.31

D1M6 Day 1 22 2.91 (2.04) 2.00, 3.81 22 5.27 (2.24) 4.28, 6.27

Month 6 22 2.84 (1.98) 1.96, 3.72 22 5.45 (2.27) 4.44, 6.46

M3M6 Month 3 22 2.76 (2.22) 1.78, 3.74 22 5.42 (1.92) 4.57, 6.27

Month 6 22 2.66 (1.87) 1.83, 3.49 22 5.53 (1.96) 4.66, 6.40


Month 3 22 2.20 (1.11) 1.70, 2.69 22 3.57 (1.25) 3.01, 4.12

D1M6 Day 1 22 2.13 (1.10) 1.64, 2.61 22 3.51 (1.23) 2.96, 4.05

Month 6 22 2.11 (1.15) 1.60, 2.62 22 3.56 (1.29) 2.98, 4.13

M3M6 Month 3 22 2.09 (1.13) 1.59, 2.59 22 3.64 (1.07) 3.17, 4.12

Month 6 22 2.06 (1.11) 1.57, 2.55 22 3.71 (1.21) 3.17, 4.25


Month 3 22 2.75 (2.03) 1.85, 3.65 22 5.32 (2.16) 4.36, 6.27

D1M6 Day 1 22 2.84 (1.97) 1.96, 3.71 22 5.24 (2.11) 4.31, 6.18

Month 6 22 2.73 (1.88) 1.90, 3.56 22 5.37 (2.12) 4.43, 6.31

M3M6 Month 3 22 2.69 (1.97) 1.81, 3.56 22 5.32 (1.75) 4.54, 6.09

Month 6 22 2.58 (1.71) 1.82, 3.34 22 5.44 (1.84) 4.62, 6.25


Month 3 23 4.22 (1.24) 3.69, 4.76 23 3.31 (0.80) 2.96, 3.65

D1M6 Day 1 23 4.19 (1.18) 3.68, 4.70 23 3.31 (0.80) 2.97, 3.66

Month 6 23 4.19 (1.04) 3.74, 4.64 23 3.37 (0.81) 3.02, 3.72

26

M3M6 Month 3 23 4.14 (1.19) 3.62, 4.65 23 3.28 (0.80) 2.93, 3.63

Month 6 23 4.11 (0.99) 3.69, 4.54 23 3.34 (0.81) 2.99, 3.69


Month 3 23 2.47 (1.40) 1.86, 3.08 23 4.30 (1.49) 3.66, 4.95

D1M6 Day 1 23 2.48 (1.41) 1.86, 3.09 23 4.20 (1.48) 3.56, 4.84

Month 6 23 2.41 (1.39) 1.81, 3.01 23 4.28 (1.52) 3.62, 4.94

M3M6 Month 3 23 2.37 (1.37) 1.78, 2.97 23 4.31 (1.21) 3.79, 4.83

Month 6 23 2.32 (1.28) 1.76, 2.87 23 4.39 (1.33) 3.81, 4.96

Total D1M3 Day 1 23 6.75 (2.31) 5.75, 7.75 23 7.57 (2.04) 6.69, 8.46

Month 3 23 6.69 (2.28) 5.71, 7.68 23 7.61 (2.06) 6.72, 8.50

D1M6 Day 1 23 6.66 (2.24) 5.70, 7.63 23 7.51 (1.98) 6.66, 8.37

Month 6 23 6.60 (1.99) 5.74, 7.46 23 7.65 (2.04) 6.76, 8.53

M3M6 Month 3 23 6.51 (2.25) 5.53, 7.48 23 7.59 (1.81) 6.81, 8.37

Month 6 23 6.43 (1.86) 5.62, 7.24 23 7.72 (1.92) 6.89, 8.55

Trachea and Bronchus Measurements (Day 1) Lung volume: FRC Lung volume: TLC

Parameters Lung Location n Mean (SD) 95% CI n Mean (SD) 95% CI

iVaw (mL)

Trachea 23 13.98 (6.56) 11.14, 16.81 23 26.25 (8.65) 22.51, 29.99

Main Bronchus Left 23 4.58 (1.71) 3.84, 5.31 23 7.28 (2.25) 6.31, 8.25

Main Bronchus Right 23 3.41 (1.38) 2.81, 4.00 23 5.19 (1.70) 4.46, 5.93

Length (mm) Trachea 23 63.12 (15.59) 56.37, 69.86 23 85.56 (17.92) 77.81, 93.31

27



Diameter (mm)

Trachea 23 0.52 (0.09) 0.48, 0.55 23 0.62 (0.07) 0.59, 0.65



Airway X-Direction (unit vector)

Trachea 23 0.03 (0.11) -0.02, 0.07 23 -0.04 (0.06) -0.06, -0.01


Main Bronchus Right 23 -0.72 (0.12) -0.77, -0.67 23 -0.72 (0.12) -0.77, -0.67

Airway Y-Direction (unit vector)

Trachea 23 0.35 (0.11) 0.30, 0.40 23 0.27 (0.11) 0.23, 0.32



Airway Z-Direction (unit vector)

Trachea 23 -0.92 (0.05) -0.94, -0.90 23 -0.95 (0.03) -0.97, -0.94

Main Bronchus Left 23 -0.51 (0.08) -0.55, -0.48 23 -0.57 (0.08) -0.60, -0.54

Main Bronchus Right 23 -0.57 (0.12) -0.63, -0.52 23 -0.62 (0.14) -0.68, -0.56

Parameter: Lobar Volume (iVlobe) (L) Lung volume: FRC Lung volume: TLC

Lung Location Visit n Mean (SD) 95% CI n Mean (SD) 95% CI

RUL Day 1 23 0.68 (0.33) 0.54, 0.82 23 1.10 (0.49) 0.89, 1.31

28

Month 3 23 0.66 (0.34) 0.51, 0.81 23 1.10 (0.51) 0.88, 1.32

Month 6 23 0.67 (0.38) 0.50, 0.83 23 1.08 (0.51) 0.86, 1.30

LUL Day 1 22 0.74 (0.28) 0.61, 0.87 22 1.20 (0.41) 1.02, 1.38

Month 3 22 0.74 (0.30) 0.60, 0.87 22 1.21 (0.42) 1.03, 1.40

Month 6 22 0.74 (0.32) 0.59, 0.88 22 1.19 (0.42) 1.01, 1.38

RML Day 1 23 0.31 (0.16) 0.24, 0.38 23 0.46 (0.21) 0.37, 0.55

Month 3 23 0.30 (0.15) 0.24, 0.37 23 0.47 (0.21) 0.37, 0.56

Month 6 23 0.30 (0.15) 0.23, 0.36 23 0.45 (0.20) 0.37, 0.54

RLL Day 1 23 0.49 (0.21) 0.40, 0.58 23 0.95 (0.42) 0.77, 1.13

Month 3 23 0.49 (0.21) 0.40, 0.58 23 0.95 (0.40) 0.78, 1.13

Month 6 23 0.48 (0.17) 0.41, 0.56 23 0.93 (0.39) 0.76, 1.10

LLL Day 1 22 0.54 (0.21) 0.45, 0.64 22 1.04 (0.43) 0.84, 1.23

Month 3 22 0.54 (0.21) 0.44, 0.63 22 1.04 (0.43) 0.84, 1.23

Month 6 22 0.53 (0.20) 0.45, 0.62 22 1.01 (0.42) 0.82, 1.19

Upper Day 1 22 1.76 (0.63) 1.48, 2.04 22 2.81 (0.90) 2.41, 3.21

Month 3 22 1.74 (0.66) 1.45, 2.03 22 2.84 (0.94) 2.42, 3.26

Month 6 22 1.73 (0.71) 1.42, 2.05 22 2.79 (0.92) 2.38, 3.19

Lower Day 1 22 1.03 (0.39) 0.86, 1.20 22 1.98 (0.81) 1.62, 2.34

Month 3 22 1.02 (0.39) 0.85, 1.19 22 1.98 (0.80) 1.63, 2.33

Month 6 22 1.01 (0.33) 0.86, 1.16 22 1.93 (0.78) 1.59, 2.28

Total Day 1 23 2.73 (0.93) 2.33, 3.13 23 4.69 (1.52) 4.03, 5.34

Month 3 23 2.70 (0.95) 2.29, 3.11 23 4.71 (1.53) 4.05, 5.38

Month 6 23 2.69 (0.92) 2.29, 3.09 23 4.61 (1.49) 3.97, 5.26

29

Parameter: Internal Airflow Lobar Distribution (%) [Relative lobar change from FRC to TLC]

Lung Location Visit n Mean (SD) 95% CI

RUL Day 1 23 20.85 (6.63) 17.99, 23.72

Month 3 23 21.11 (7.14) 18.03, 24.20

Month 6 23 21.08 (6.52) 18.26, 23.90

LUL Day 1 22 23.19 (4.65) 21.13, 25.25

Month 3 22 23.08 (4.60) 21.04, 25.12

Month 6 22 23.64 (4.94) 21.45, 25.83

RML Day 1 23 8.16 (3.47) 6.66, 9.66

Month 3 23 8.21 (2.82) 6.99, 9.43

Month 6 23 8.63 (3.22) 7.24, 10.02

RLL Day 1 23 23.73 (8.74) 19.96, 27.51

Month 3 23 23.80 (8.11) 20.29, 27.31

Month 6 23 23.26 (7.80) 19.89, 26.63

LLL Day 1 22 24.41 (5.27) 22.08, 26.75

Month 3 22 24.18 (5.65) 21.67, 26.69

Month 6 22 23.75 (5.40) 21.35, 26.14

Upper Region Day 1 22 53.06 (9.99) 48.64, 57.49

Month 3 22 53.25 (9.43) 49.07, 57.43

Month 6 22 54.21 (8.49) 50.44, 57.97

Lower Region Day 1 22 46.94 (9.99) 42.51, 51.36

Month 3 22 46.75 (9.43) 42.57, 50.93

Month 6 22 45.79 (8.49) 42.03, 49.56

30

Parameter: Blood Vessel Density using Contrast (% of iVlobe) Lung Volume: TLC

Lung Location Visit n Mean (SD) 95% CI

RUL Day 1 15 5.51 (4.54) 3.00, 8.03

Month 6 15 5.96 (4.76) 3.33, 8.59

LUL Day 1 14 4.47 (1.64) 3.52, 5.42

Month 6 14 4.97 (2.60) 3.47, 6.48

RML Day 1 15 5.39 (2.38) 4.07, 6.71

Month 6 15 5.88 (3.14) 4.14, 7.62

RLL Day 1 15 7.98 (4.54) 5.46, 10.50

Month 6 15 8.85 (4.34) 6.45, 11.26

LLL Day 1 14 6.41 (3.14) 4.60, 8.22

Month 6 14 6.92 (3.11) 5.13, 8.72

Upper Region Day 1 14 4.55 (1.81) 3.51, 5.60

Month 6 14 4.95 (2.34) 3.60, 6.30

Lower Region Day 1 14 7.10 (3.64) 5.00, 9.20

Month 6 14 7.82 (3.58) 5.76, 9.89

Total Day 1 15 5.67 (2.23) 4.43, 6.90

Month 6 15 6.06 (2.43) 4.71, 7.40

Lung function Endpoints [from Spirometry]

FVC (L) FEV1 (L)

Visit n Mean (SD) 95% CI Mean (SD) 95% CI

Day 1 23 2.86 (1.14) 2.36, 3.35 2.29 (0.81) 1.94, 2.64

31

Month 3 23 2.88 (1.19) 2.36, 3.39 2.27 (0.81) 1.92, 2.62

Month 6 23 2.84 (1.16) 2.34, 3.34 2.25 (0.81) 1.90, 2.60

Month 12 11 3.17 (1.47) 2.19, 4.16 2.39 (0.98) 1.73, 3.05

VMAX25 (L/sec) VMAX50 (L/sec)


Day 1 23 1.12 (0.82) 0.76, 1.47 3.62 (1.95) 2.77, 4.46

Month 3 23 0.97 (0.53) 0.74, 1.19 3.77 (2.03) 2.89, 4.65

Month 6 23 0.89 (0.49) 0.68, 1.10 3.76 (2.03) 2.88, 4.64

Month 12 11 0.82 (0.47) 0.51, 1.14 3.17 (1.87) 1.91, 4.42

PEFR (L/sec) PIFR (L/sec)


Day 1 23 7.85 (2.44) 6.80, 8.91 5.16 (1.41) 4.55, 5.77

Month 3 23 7.86 (2.30) 6.87, 8.86 5.17 (1.54) 4.50, 5.83

Month 6 23 7.87 (2.47) 6.80, 8.93 5.22 (1.57) 4.54, 5.89

Month 12 11 7.39 (2.10) 5.98, 8.80 4.60 (0.96) 3.96, 5.25

Diffusion Capacity Endpoints

DLco (mmol/min.kPa) Kco (mmol/min.kPa.L)


Day 1 19 3.19 (1.36) 2.53, 3.85 0.81 (0.24) 0.70, 0.93

Month 3 23 3.01 (1.30) 2.45, 3.57 0.80 (0.23) 0.70, 0.91

Month 6 22 2.96 (1.36) 2.36, 3.57 0.80 (0.25) 0.69, 0.90

Month 12 11 3.40 (1.42) 2.44, 4.36 0.85 (0.29) 0.66, 1.05

32

Whole Body Plethysmography Endpoints

TLC (L) Residual Volume (L) FRC (L)

Visit n Mean (SD) 95% CI Mean (SD) 95% CI Mean (SD) 95% CI

Day 1 23 4.67 (1.43) 4.05, 5.29 1.78 (0.47) 1.58, 1.99 2.54 (0.96) 2.12, 2.96

Month 3 23 4.65 (1.47) 4.01, 5.29 1.74 (0.53) 1.51, 1.97 2.52 (0.93) 2.12, 2.92

Month 6 23 4.54 (1.54) 3.87, 5.21 1.69 (0.53) 1.46, 1.91 2.45 (0.95) 2.04, 2.86

Month 12 11 4.99 (1.80) 3.79, 6.20 1.76 (0.48) 1.44, 2.08 2.80 (1.21) 1.99, 3.61

Airway Resistance (kPa.s/L) Specific airway resistance (kPa.s) Conductance (1/kPa.s/L) Specific conductance (1/kPa.s)

Visit n Mean (SD) 95% CI Mean (SD) 95% CI Mean (SD) 95% CI Mean (SD) 95% CI

Day 1 23 0.31 (0.19) 0.23, 0.40 0.82 (0.44) 0.63, 1.01 3.98 (1.50) 3.33, 4.63 1.52 (0.72) 1.21, 1.83

Month 3 23 0.28 (0.11) 0.23, 0.33 0.79 (0.35) 0.64, 0.94 4.05 (1.33) 3.47, 4.62 1.40 (0.39) 1.24, 1.57

Month 6 23 0.33 (0.19) 0.24, 0.41 0.89 (0.51) 0.67, 1.11 3.74 (1.40) 3.13, 4.35 1.33 (0.45) 1.14, 1.52

Month 12 11 0.28 (0.15) 0.18, 0.38 0.82 (0.30) 0.62, 1.03 4.25 (1.58) 3.19, 5.31 1.37 (0.53) 1.01, 1.73

Secondary Outcome Results: Not applicable

Safety Results: As the subjects did not receive any treatment during the study, there were no on-therapy AEs or SAEs.

Conclusion: The lung function, inhalation profiles, airway morphometry and pharyngometry of IPF subjects have been summarized. As the subjects did not receive any treatment during the study, there were no on-therapy AEs or SAEs.

Date post:	03-Apr-2018
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