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Effects of Macrolides on Asthma Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852579
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : October 19, 2011
University of Glasgow
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Euan J Cameron, University of Glasgow

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Azithromycin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.
Study Start Date : March 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1
Active treatment.
Drug: Azithromycin
Daily dose 250mg

Placebo Comparator: 2
Placebo control group.
Drug: Placebo

Primary Outcome Measures :
  1. Peak expiratory flow rate. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852579

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United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Crosshouse Hospital
Kilmarnock, United Kingdom, KA2 0BE
Sponsors and Collaborators
Euan J Cameron
University of Glasgow
NHS Greater Glasgow and Clyde
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Principal Investigator: Neil C Thomson, FRCP University of Glasgow
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Euan J Cameron, Clinical Research Fellow - Respiratory Medicine, University of Glasgow Identifier: NCT00852579    
Other Study ID Numbers: AR010
EUDRACT 2008-007240-34
MRC Grant G0701626
NRES 09/S0703/23
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: October 19, 2011
Last Verified: October 2011
Keywords provided by Euan J Cameron, University of Glasgow:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents