Asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Asthmatics • Male or Female aged between 18-80 years old • Clinical diagnosis of refractory Asthma • Symptomatic despite receiving treatment at step 4 of the BTS asthma guidelines: 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. Controls • Male or Female aged between 18-80 years old • Never Smoker • No Respiratory Disease 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
Exclusion criteria: Asthmatics • Pregnant Females • Inadequate Contraception or Lactation • Antibiotic course within the last 6 weeks • Smoking history in excess of 20 pack years • Clinical diagnosis of ABPA • Bronchiectasis • Abnormal liver function tests • History of liver disease • Medication known to interact with azithromycin (e.g. ciclosporin, digoxin, ergot derivatives, terfenadine, warfarin, antacids, and ritonavir) Controls • Pregnant females • Antibiotic course within the last 6 weeks • Abnormal liver function tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in validated symptom scores (Juniper Asthma Control Questionnaire); Main Objective: PURPOSE The purpose of this study is to better understand the mechanistic effects of Azithromycin (AZM) in asthma, and to establish if AZM therapy is effective in a subgroup of patients with chronic asthma who have phenotypically distinct disease PRIMARY OBJECTIVE • To study the effects of AZM in well phenotyped patients with asthma. ; Secondary Objective: • To determine if the clinical response to AZM therapy relates to the underlying asthma phenotype(individually distinct characteristics), including presence or absence of bacterial infection, or inflammatory subtype (eosinophilic vs. neutrophilic). • To ascertain whether the in vitro response of human bronchial epithelia cells to AZM predicts the clinical response and provide a greater insight into the mechanism of action of this compound. | — |
Countries
United Kingdom
Outcome results
None listed