Refractory asthma Respiratory Asthma
Conditions
Interventions
Azithromycin 250 mg three times a week for six weeks versus matching placebo three times a week for six weeks.
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-smoking subjects 2. Aged 16 to 80 years, either sex 3. Refractory asthma, forced expiratory volume in one second (FEV1) greater than 50% predicted and greater than 1L and measurable airway responsiveness to methacholine challenge Refractory asthma will be defined as an FEV1/forced vital capacity (FVC) ratio less than 70% with evidence of poor asthma control in terms of regular night-time awakening (greater than 2/week) or more than four puffs of relief medication/day (greater than twice/week) requiring repeated (two or more per year) courses of oral corticosteroids despite treatment with high dose inhaled corticosteroids (at least 1000 µg beclomethasone or equivalent) and treatment with, or a previous unsuccessful trial of, a long-acting beta-agonist or leukotriene antagonist.
Exclusion criteria
Exclusion criteria: 1. Poor compliance with usual asthma treatment 2. Pregnancy 3. Inadequate contraception or lactation 4. Active smoking or smoking history in excess of 20 pack years 5. A clinical diagnosis of allergic bronchopulmonary aspergillosis or significant bronchiectasis 6. Other major co-morbidity including abnormal liver function tests or medication known to interact with azithromycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchial reactivity (the dose of methacholine producing a 20 percent fall in FEV1 [PD20 methacholine]). Primary and secondary outcomes measured at the end of each 6 week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of exacerbations requiring treatment with oral corticosteroids 2. Number of exacerbations requiring an increase in asthma therapy 3. Total dose of oral corticosteroids taken during the treatment period 4. Inhaled corticosteroid use 5. Reliever medication use 6. FEV1 7. Peak expiratory flow (PEF) 8. Exhaled nitric oxide 9. Blood and sputum differential cell counts 10. Asthma symptoms 11. Asthma Control Questionnaire (ACQ) score 12. Asthma Quality of Life Questionnaire (AQLQ) 13. Liver function tests 14. Adverse effects 15. Participants' views on study design, acceptability and issues that would be important to consider when designing a larger trial Primary and secondary outcomes measured at the end of each 6 week treatment period. | — |
Countries
United Kingdom
Outcome results
None listed