Status:
UNKNOWN
An Open Label Trial of Azithromycin in Chronic Productive Cough
Lead Sponsor:
University of Nottingham
Conditions:
Chronic Cough
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
We have noticed a group of patients presenting with a longstanding wet cough which has often been treated as asthma. The cough is productive of sputum which frequently contains bacteria, but does not ...
Detailed Description
We and others have observed a cohort of patients, mainly referred with either poorly controlled asthma despite high dose treatment or suspected bronchiectasis, who give a history of chronic (often 3 m...
Eligibility Criteria
Inclusion
- Age 18 and over
- 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.
Exclusion
- History of obvious inhaled irritant exposure
- Evidence of primary or secondary immunodeficiency.
- Clinically important bronchiectasis on HRCT scan
- Prolonged QT interval on ECG or significant cardiac pathology prior to commencing azithromycin
- Abnormal LFT's (greater than 2x upper limit of normal)
- Hypersensitivity to azithromycin or any macrolide/ketolide antibiotic
- Pregnancy or intent to become pregnant during course of study
- Contra-indication to bronchoscopy (as per British Thoracic Society Guidelines)
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02196493
Start Date
December 1 2013
End Date
December 1 2016
Last Update
February 18 2016
Active Locations (1)
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1
Respiratory Research Unit
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB