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NCT Number: NCT00852579

Effects of Macrolides on Asthma Control

Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gartnavel General Hospital, Glasgow, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of asthma
  • Age 18-70
  • Current smoker
  • Duration of symptoms >1yr with stability for 4 weeks
  • Able to maintain asthma without exacerbations during run in period
  • Able to wean off other asthma medication

Exclusion criteria

  • Ex-smokers or never smokers
  • Planning to quit smoking during duration of trial
  • Patients with unstable asthma
  • Patients with current epilepsy, psychosis or history of significant atrial or ventricular tachyarrhythmia
  • Corrected QT-interval greater than 450msec in women, 430msec in men
  • Low potassium levels. If can be corrected then screening can continue with confirmation of normal levels prior to taking study medication
  • Liver disease (ALT and/or AST levels 2 or more times ULN)
  • Significant renal disease (Creatinine or urea levels 2 or more times ULN)
  • Any previous severe adverse reactions to macrolides
  • Patients who are known to have specific IgE sensitivity or skin test positivity to grass pollen and a history of worsening of asthma due to hay fever will not be recruited from mid May to the end of July
  • Upper or lower respiratory tract infection in the 4 weeks prior to randomisation. Run in period can be prolonged in this situation to have 4 weeks with no respiratory infection prior to randomisation.
  • Patients who require medications known to interact with azithromycin
  • On other immunosuppressants or chronic antibiotics
  • Weight less than 45kg
  • Frequent asthma exacerbations (greater than 4) requiring oral corticosteroids in the year prior to randomisation
  • Current or past diagnosis of allergic-bronchopulmonary-aspergillosis
  • Pregnancy and breast feeding
  • Mental impairment or language difficulties that makes informed consent not possible

Treatment and study plan

Azithromycin

Drug

Daily dose 250mg

Placebo

Drug

Placebo

Primary outcomes

  1. Peak expiratory flow rate.

    Time frame: 12 weeks

Secondary outcomes

  1. Spirometry

    Time frame: 12 weeks

  2. Asthma control score

    Time frame: 12 weeks

  3. Average of last 7 days PEF measurements

    Time frame: 12 weeks

  4. Sputum cell counts

    Time frame: 12 weeks

  5. Fraction of expired nitric oxide

    Time frame: 12 weeks

  6. Airway responsiveness to methacholine

    Time frame: 12 weeks

  7. Exacerbation rates

    Time frame: 12 weeks

  8. Cough score

    Time frame: 12 weeks

  9. Diary symptom score

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Euan J Cameron

Other

Collaborators

  • NHS Greater Glasgow and Clyde
  • University of Glasgow

Registry information

Official study title

Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 27, 2009
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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