An Open Label Trial of Azithromycin in Chronic Productive Cough

NCT02196493 | Unknown Phase 3

• 2 other identifiers: 130312013-002938-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 resolve with standard antibiotic treatment. A very similar cough is seen in subjects who smoke, have exposure to airbourne dusts or chemicals or have a condition known as bronchiectasis, but these problems have already been excluded. We have found that prolonged treatment with an antibiotic called azithromycin is very effective but using azithromycin in this way is not licensed and there is currently no trial evidence to support its use. This research will evaluate the clinical benefit of low dose azithromycin to determine if this is an effective and safe treatment for these patients. It will also involve a detailed investigation of these patients to determine whether they have enough in common to believe we are describing a new condition.

Conditions

Chronic Cough

Keywords

Productive; Cough; Bronchitis; Azithromycin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in cough on the Leicester Cough Questionnaire (LCQ) score at week 12

  12 weeks after treatment started

Secondary Outcomes (4)

• Change from baseline in sputum colour (as per previously validated commercially available graded sputum colour chart) at week 12

  12 weeks after treatment started

• Change from baseline in exhaled nitric oxide level (ppm) at week 24

  12 weeks after treatment started

• Change from baseline in FEV1 (ml) at week 24

  12 weeks after treatment started

• Change from baseline in sputum volume (ml) at week 12

  12 weeks after treatment started

Study Arms (1)

Azithromycin

EXPERIMENTAL

250mg azithromycin three times weekly for 12 weeks

Drug: Azithromycin

Interventions

Azithromycin DRUG

250mg azithromycin three times per week for 12 weeks

Also known as: Zithromax

Azithromycin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Respiratory Research Unit

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

Related Publications (1)

• Martin MJ, Lee H, Clayton C, Pointon K, Soomro I, Shaw DE, Harrison TW. Idiopathic chronic productive cough and response to open-label macrolide therapy: An observational study. Respirology. 2019 Jun;24(6):558-565. doi: 10.1111/resp.13483. Epub 2019 Feb 5.

  PMID: 30722097 DERIVED

MeSH Terms

Conditions

Chronic Cough; Cough; Bronchitis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Tim Harrison, MD, FRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Martin, MBChB

CONTACT

01158231935; matthew.martin@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 22, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 18, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)