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Effects of Macrolides on Asthma Control

This study has been completed.
Sponsor:
Collaborators:
University of Glasgow
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Euan J Cameron, University of Glasgow
ClinicalTrials.gov Identifier:
NCT00852579
First received: February 26, 2009
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Asthma
 Drug: Azithromycin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.

Resource links provided by NLM:

MedlinePlus related topics: Asthma Smoking
U.S. FDA Resources

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Peak expiratory flow rate. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spirometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Asthma control score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Average of last 7 days PEF measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sputum cell counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fraction of expired nitric oxide [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Airway responsiveness to methacholine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Exacerbation rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cough score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Diary symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: March 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active treatment.
 Drug: Azithromycin
Daily dose 250mg
Placebo Comparator: 2
Placebo control group.
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852579

Locations
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
Investigators
Principal Investigator: Neil C Thomson, FRCP University of Glasgow
  More Information

Publications:

Responsible Party: Euan J Cameron, Clinical Research Fellow - Respiratory Medicine, University of Glasgow
ClinicalTrials.gov Identifier: NCT00852579     History of Changes
Other Study ID Numbers: AR010, EUDRACT 2008-007240-34, MRC Grant G0701626, NRES 09/S0703/23
Study First Received: February 26, 2009
Last Updated: October 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:
Asthma
Smoker
Macrolide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013