Status:
COMPLETED
Effects of Macrolides on Asthma Control
Lead Sponsor:
Euan J Cameron
Collaborating Sponsors:
University of Glasgow
NHS Greater Glasgow and Clyde
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00852579
Start Date
March 1 2009
End Date
August 1 2011
Last Update
October 19 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
2
Crosshouse Hospital
Kilmarnock, United Kingdom, KA2 0BE