Predicting Response to Azithromycin Therapy in Asthma - Azithromycin in Asthma

Phase 1

• Conditions: Asthma; MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2011-000237-36-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-30
• Study Completion: 2013-05-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

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

Study & Design

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