Macrolides in Refractory Asthma

Phase 1

• Conditions: Refractory asthma; MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

• Registration Number: EUCTR2007-006576-11-GB
• Lead Sponsor: ottingham University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-02
• Study Completion: 2013-02-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Non-smoking subjects aged 16 to 80 with refractory asthma, FEV1 >50% predicted and >1L and measurable airway responsiveness to methacholine challenge. Refractory asthma will be defined as an FEV1/FVC ratio less than 70% with evidence of poor asthma control in terms of regular night-time awakening (>2/week) or more than 4 puffs of relief medication/day (>twice/week) requiring repeated (2 or more per year) courses of oral corticosteroids despite treatment with high dose inhaled corticosteroids (=1000mg beclomethasone or equivalent) and treatment with, or a previous unsuccessful trial of, a long-acting beta-agonist or leukotriene antagonist.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Poor compliance with their usual asthma treatment as assessed by a review of primary care records, pregnancy, inadequate contraception or lactation, active smoking or smoking history in excess of 20 pack years, a clinical diagnosis of ABPA or significant bronchiectasis, other major co-morbidity including abnormal liver function tests or medication known to interact with azithromycin (aprepitant, atazanavir, atorvastatin, carbamazepine, ciclosporin, colchicine, disopyramide, efavirenz, eletriptan, eplerenone, itraconazone, ivabradine, methylprednisolone, midazolam, omeprazole, phenytoin, pimozide, repaglinide, ritabutin, rifamycins, ritonavir, sildenafil, simvastatin, sirolimus, tacrolimus, tadalafil, theophylline, tipranavir, tolterodine, verapamil, warfarin and zidovudine)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether macrolides improve bronchial hyperresponsiveness in patients with refractory asthma;<br> Secondary Objective: To provide information on the exacerbation rate in patients with refractory asthma<br> To demonstrate the feasibility of treating patients with refractory asthma with a macrolide<br> ;Primary end point(s): Change from baseline in bronchial reactivity (PD20 methacholine)