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Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc
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Page 1: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Respiratory system diseases: overview of national guidelines and clinical

management of asthma and COPD in primary care.

Roberta Luzzi, PharmD, MSc

Page 2: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Ischaemic heart disease, stroke, lower respiratory infections and chronic obstructive lung disease have remained the top major killers during the past decade.

WHO Fact sheet N°310 . Updated May 2014

Page 3: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Asthma is a syndrome characterised by airflow obstruction that varies from person to person.

Narrowing of the airways is usually reversible but in some patients with chronic asthma there may be irreversible airflow obstruction.

Asthmatics develop an inflammation in the airways that makes them more responsivethan non asthmatic individuals to a wide range of triggers, leading to excessive narrowing with consequent reduced airflow and symptomatic wheezing and dyspnea.

Asthma is a heterogeneous disease with interplay between genetic and environmental factors (allergens, diet, air pollution,occupational exposure..)

Airway hyperresponsiveness (AHR) is the characteristic physiologic abnormality of asthma and describes the excessive bronchoconstrictor response to multiple inhaled triggers that would not have effect on normal airways.

Asthma is one of the most common chronic disease globally and currently affects 300million people worldwide (approximately 10-12% adults and 15% children). It is rising in developing countries due to the increased urbanisation.

Longo et al. Harrisons’ principle of internal medicine

ASTHMA

Page 4: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

allergens

virus infections Pharmacologic agents(Beta blocker;Non selective COX inhibitors)

Exercise

air pollution

Food

Occupational factors

Hormonal factors

Gastroesophageal reflux

stress

Asthma

Page 5: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Asthma

Non pharmacologic approach Pharmacologic approach

TRIGGERS

Page 6: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Pharmacologic approach of asthma

BRONCHODILATORS

immediate relief of symptoms with relaxation of airway smooth muscles

β2 agonists Anticholinergics Theophylline

CONTROLLERS

inhibit the underlying inflammatory process

Inhaled corticosteroids Oral corticosteroids Antileuokotrienes(ICS) (OCS)

Main drugs and most effective at present

Roberta Luzzi
bronchodilators provide immediate relief of symptoms by reversing the bronchoconstriction of asthma acting on airway smooth muscles. they do not act at all on the inflammation process of asthma and they are not sufficient to control asthma in patients with persistent symptoms. controllers act on the inflammation involved in asthma.
Page 7: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

β2 agonists

• Relax airway smooth-muscle cells

• Act as functional antagonists of all known bronchoconstrictors

β2 agonists activate β2 receptors widely expressed in the airways

Great efficacy as bronchodilators in asthma

BRONCHODILATORS

Page 8: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Short acting β2 agonists(SABAs)

Albuterol Terbutalin

Duration of action 3-6hrs;Rapid onset of effect;MDI; DPIHigh doses via nebulizers

Used as needed for symptom relief

Prevention of exercised induced asthma

Long acting β2 agonists(LABAs)

Salmeterol Formoterol

Duration of action > 12hrs;Twice a dayMDI; DPI

Used to improve control of symptomsALWAYS combined with ICS (combined inhalers LABA/ICS achieve effective asthma control)

BRONCHODILATORS

Page 9: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Side effects

• Not usually an issue when β2 agonists are given via inhalation.• Most common are tremors and palpitations

(especially in elderly patients)

• Tolerance: not an major problem due to the high presence of receptors in the airways

Frequent use of SABAs indicates that asthma is NOT under control

BRONCHODILATORS

Page 10: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Anticholinergics• Ipratropium bromide (MDI, nebulisers)

• Muscarinic receptor antagonists prevent cholinergic nerve-induced bronchoconstriction and mucus secretion

• Not as effective as β2 agonists as they only act on the cholinergic reflex component of bronchocontriction.

• Used as additional bronchodilators when asthma not controlled

• Side effects: dry mouth; in elderly patients urinary retention, glaucoma (very little absorption systemically)

BRONCHODILATORS

Page 11: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Theophylline

• It was widely prescribed as bronchodilator but now replaced by β2 agonists as more effective and for less incidence of side effects

• Inhibition of phosphodiesterases in smooth muscle cells

• SR formulation once or twice a day as additional bronchodilator in patients with severe asthma.

• Side effects are related to plasma concentration (it should be monitored). Side effects not common at concentrations below 10mg/L. Most common: nausea, vomiting, headaches, diuresis, palpitations. At high concentrations cardiac arrhythmias, epileptic seizures and death.

• Theophylline is metabolised by CYP450.

BRONCHODILATORS

Page 12: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Increased clearance:

• Enzyme induction (rifampicin, phenobarbitone, ethanol)• Smoking• High-protein, low carbohydrate diet• Barbecued meat• Childhood

Decreased clearance

• Enzyme inhibition (cimetidine, erythromycin, ciprofloxacin, allopurinol, zileuton, zafirlukast)• Congestive heart failure• Liver disease• Pneumonia• Viral infection and vaccination• High carbohydrate diet• Old age

Fauci et al. Harrison’s principles of internal medicine.18th edition

Factors affecting clearance of theophyllineBRONCHODILATORS

Page 13: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Inhaled Corticosteroids• Inhaled corticosteroids (ICS) are the most effective controllers of asthma

• They act reducing the number of inflammatory cells and their activation in the airways

• ICS chronic use leads to a reduction of AHR. Not a cure for the underlying condition!

• Generally used twice a day but could be used once a day in mild asthma. (MDI and DPI)

• Positive effects on symptoms after a few days and long term benefit in preventing symptoms recurrence.

• Chronic use prevents irreversible changes in airway function that occur in asthma

CONTROLLERS

Page 14: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Local side effects: dysphonia and oral candidiasis

Systemic side effects: many studies have demonstrated minimal side effects from lung absorption (high recommended doses and chronic use)

LARGE VOLUME SPACER DEVICEORAL HYGENE

CONTROLLERS

Page 15: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• Used to treat acute exacerbations of asthma (for 5-10 days)

• 1% of asthma patients needs maintenance treatment (lowest dose possible to maintain control should be determined)

• More incidence of systemic side effects: diabetes, hypertension, gastric ulceration, depression, cataracts…

Oral corticosteroids CONTROLLERS

Page 16: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Antileukotrienes CONTROLLERS

• Cysteinyl-leukotrienes are inflammatory mediators mainly produced by mast cells and they induce bronchoconstriction activating cys-LT1-receptors.

• Montelukast, zafirlukast block cys-LT1-receptors inducing a modest clinical benefit.

• Used in the add-on therapy when low doses of ICS do not control symptoms (less effective thatn LABAs)

• Generally well tolerated

Page 17: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

“Stepwise approach”

BTS/SIGN *guidelines have a stepwise approach to the management of asthma in both adults and

children. The aim is to control early symptoms starting at the step most appropriate for the

patient

to achieve control

when control is goodSTEP DOWN

STEP UP

* British Thoracic Society/Scottish Intercollegiate Guidelines Network

Roberta Luzzi
Asthma management aims to control symptoms (including nocturnal symptomsand exercise-induced asthma), prevent exacerbations and achieve the bestpossible lung function, with minimal side effects of treatment. The BTS/SIGNguidelines recommend a stepwise approach to treatment in both adults andchildren. Treatment is started at the step most appropriate to the initial severityof the asthma, with the aim of achieving early control of symptoms andoptimising respiratory function. Control is maintained by stepping up treatmentas necessary and stepping down when control is good.
Page 18: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Stepwise management in adults

• Step 1-mild intermittent asthma Inhaled SABAwhen required

• Step 2-regular preventer therapy

• Step 3-initial add-on therapy

ICS 200-800 mcg/day

Inhaled LABA

Plus (if SABA more than twice a week or if night symptoms or exacerbation in the last 2 yrs)

plus

Good response: Continue LABA

Benefit from LABA but no control yet:

Continue LABA + ICS 800mcg/die

No benefit from LABA: Stop LABA + ICS 800mcg/die +additional therapy in no control yet (leukotriene receptor antagonist or SR theophylline)

Page 19: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• Step 4: persistent poor control

• Step 5: continuous or frequent use of oral steroids

-Increasing ICS up to 2,000 mcg/die + SABA + LABA(if effective)

-addition of a fourth drug:-leukotriene receptor

antagonist -SR theophylline-β2 agonist tablet

-Daily steroid tablet in lowest dose providing adequate control-Maintain high dose inhaled corticosteroid at 2,000mcg/die-Consider other treatments tominimise the use of steroid tablets-Refer patient for specialist care

Page 20: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Children aged 5-12 years

• Step 1-mild intermittent asthma Inhaled SABAwhen required

• Step 2-regular preventer therapy ICS 200-400 mcg/day

Inhaled LABA

Good response: Continue LABA

Benefit from LABA but no control yet:

Continue LABA + ICS 400mcg/die

No benefit from LABA: Stop LABA + ICS 400mcg/die +additional therapy in no control yet (leukotriene receptor antagonist or SR theophylline)

• Step 3-initial add-on therapy

Plus (if SABA more than twice a week or if night symptoms or exacerbation in the last 2 yrs)

plus

Page 21: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• Step 4: persistent poor control -Increasing ICS up to 800 mcg/die

-Daily steroid tablet in lowest dose providing adequate control-Maintain high dose inhaled corticosteroid at 800 mcg/die-Refer patient to respiratory paediatrician

• Step 5: continuous or frequent use of oral steroids

Page 22: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Children under 5yrs

• Step 2-regular preventer therapy

• Step 1-mild intermittent asthma

• Step 3-initial add-on therapy

• Step 4: persistent poor control

Inhaled SABAwhen required

ICS 200-400 mcg/dayOr

leukotriene receptor antagonist if ICS cannot be used

ICS + leukotriene receptor antagonist(if <2yrs go to step 4)

Refer to respiratory paediatrician

Plus (if SABA more than twice a week or if night symptoms or exacerbation in the last 2 yrs)

Page 23: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Existing therapy complian

ce

Inhaler techniqu

e

Presence of

trigger factors

Before stepping up…

Step up

People with asthma receive a structured review at least annually. Statement 5. NICE quality standard 25. February 2013

Page 24: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

COPD(chronic obstructive pulmonary disease)

COPD is a disease state characterised by AIRFLOW LIMITATION that is not fully reversible.

Airflow limitation is the main physiologic change in COPD.

COPD includes emphysema (anatomically condition characterised by destruction and enlargement of the lung alveoli), chronic bronchitis (condition with chronic cough and phlegm), small airways disease (condition where small bronchioles are norrowed).

COPD is present only if chronic airflow obstruction occurs

Persistent reduction in forced expiratory flow rates is the most typical finding in COPD.

Longo et al. Harrison’s principles of internal medicine. 18th edition.

According to the latest WHO estimates (2004), currently 64 million people have COPD and 3 million people died of COPD.

Page 25: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Air pollution

Occupational exposure

COPD RISK FACTORS

cigarette smoking

Intensity of smoking exposure determinesthe effects on pulmonary function

Page 26: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

COPD pharmacologic treatmentSMOKING CESSATION

BRONCHODILATORS: β2 agonists (SABAs, LABAs); anticholinergics (SAMAs as ipratropium bromide, LAMAs as tiotropium, aclidinium, glycopyrronium)

INHALED CORTICOSTEROIDS

ORAL CORTICOSTEROIDS (in exacerbations)

THEOPHYLLINE: it should only be used after a trial of short and long acting bronchodilators or in patients unable to have inhaled therapy (MONITOR PLASMA LEVELS AND INTERACTIONS).

OXYGEN: it is the only pharmacologic treatment that has demonstrated decrease of mortality ratein patients with COPD

MUCOLYTICS: N-acetyl cysteine

Patients should be clinically reviewed at least once a year in primary care . NICE clinical guideline 101

Page 27: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

COPD management

SABA or SAMA

Exacerbations or breathlessness

initial empirical treatment for breathlessness and exercise limitation

LABA LAMA(discontinue SAMA)

FEV1≥ 50% FEV1 < 50%

LABA + ICS LAMA(discontinue SAMA)

Persistent exacerbations

LABA+

LAMA+

ICS

SABA+

ICS

Page 28: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• The spacer should be compatible with the pMDI being used.

• The drug should be administered by repeated single actuations of the metered dose inhaler into the spacer, each followed by inhalation.

• There should be minimal delay between pMDI actuation and inhalation.

• Spacers should be cleaned no more than monthly as more frequent cleaning affects their performance (because of a build up of static). They should be cleaned with water and washing-up liquid and allowed to air dry. The mouthpiece should be wiped clean of detergent before use.

• In children, pMDI and spacer are the preferred method of delivery of β2 agonists or inhaled corticosteroids. A face mask is required until the child can breathe reproducibly using the spacer mouthpiece. Where this is ineffective a nebuliser may be required.

SIGN 141 • British guideline on the management of asthma

Spacer devices

Page 29: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• The most common reason for poor control of asthma is non compliance with medications, in particular with ICS as patients do not feel immediate relief of symptoms.

Longo et al.

• People with asthma and COPD are given specific training and assessment in inhaler technique before starting any new inhaler treatment.

Statement 5. Nice quality standard 25

NICE clinical guideline 101

• Ask opened questions when doing your clinical review!!

Before we finish…

Page 30: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• British National Formulary. 69th edition

• Longo et al. Harrison’s principles of internal medicine. 18th edition

• NICE TA 10. Guidance on the use of inhaler systems (devices) in children under the age of 5 years with chronic asthma. August 2000

• NICE TA 38. Inhaler devices for routine treatment of chronic asthma in older children (aged 5–15 years). March 2002

• NICE CG 101. Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update). June 2010

• NICE TA 131. Inhaled corticosteroids for the treatment of chronic asthma in children under the age of 12 years. November 2007

• NICE TA 138. Inhaled corticosteroids for the treatment of chronic asthma in adults and in children aged 12 years and over. March 2008

• SIGN 141. British guideline on the management of asthma. October 2014

References

Page 32: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

• Napp Pharmaceuticals, Christian Saunders

• LPC, Rita Bali

Acknowledgments

Page 33: Respiratory system diseases: overview of national guidelines and clinical management of asthma and COPD in primary care. Roberta Luzzi, PharmD, MSc.

Thank you!


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