Trial of azithromycin treatment in patients with chronic wet cough

Phase 1

• Conditions: The medical condition that will be investigated is that of chronic productive cough (with or without a diagnosis of asthma but without a diagnosis of bronchiectasis, smoking related chronic bronchitis or obvious immunodeficiency); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-002938-20-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-11
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Selection criteria for patients with chronic productive cough:
- Age 18 or above (no upper age limit)
- Male or female
- Non-smokers for 10 years and <20 pack year equivalents in total
- Persistent productive cough for > 3 months in duration
- Use of effective contraception:
Acceptable contraceptive methods include: established use of oral, injected or implanted hormonal methods; placement of an intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide; true abstinence (when this is in line with the preferred and usual lifestyle of the participant); or vasectomised partner.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Exclusion criteria for patients with chronic productive cough:
- History of obvious inhaled irritant exposure
- Evidence of primary or secondary immunodeficiency.
- Clinically important bronchiectasis on HRCT scan
- Prolonged QT interval on baseline or 1 month ECG or significant cardiac pathology prior to commencing azithromycin
- Pregnancy or intent to become pregnant during course of study
- Contra-indication to bronchoscopy (British Thoracic Society Guidelines)
- Abnormal LFT’s (greater than 2x upper limit of normal)

Study & Design

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