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An Open Label Trial of Azithromycin in Chronic Productive Cough (AZCC)

This study is currently recruiting participants.
Verified February 2016 by University of Nottingham
Sponsor:
ClinicalTrials.gov Identifier:
NCT02196493
First Posted: July 22, 2014
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Nottingham
  Purpose

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.


Condition Intervention Phase
Chronic Cough Drug: Azithromycin Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Azithromycin in Chronic Productive Cough

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Change from baseline in cough on the Leicester Cough Questionnaire (LCQ) score at week 12 [ Time Frame: 12 weeks after treatment started ]

Secondary Outcome Measures:
  • Change from baseline in sputum colour (as per previously validated commercially available graded sputum colour chart) at week 12 [ Time Frame: 12 weeks after treatment started ]
  • Change from baseline in exhaled nitric oxide level (ppm) at week 24 [ Time Frame: 12 weeks after treatment started ]
  • Change from baseline in FEV1 (ml) at week 24 [ Time Frame: 12 weeks after treatment started ]
  • Change from baseline in sputum volume (ml) at week 12 [ Time Frame: 12 weeks after treatment started ]

Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin
250mg azithromycin three times weekly for 12 weeks
Drug: Azithromycin
250mg azithromycin three times per week for 12 weeks
Other Name: Zithromax

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 months or more) productive cough which improves with antibiotic treatment but quickly relapses. Most deny wheeze and on examination there are often transmitted sounds from mucus in the large airways but no expiratory wheeze typical of asthma. Investigations including spirometry, bronchial challenges, chest X-ray, screen for immunodeficiency and high resolution CT (HRCT) scan exclude recognised causes of productive cough but sputum culture is often positive for Haemophilus influenzae although sometimes demonstrates normal respiratory flora despite being markedly purulent.

Due to their efficacy in cystic fibrosis and bronchiectasis we have empirically tried treatment with low dose macrolide antibiotics over 3-6 months often with dramatic benefit. This is however an unproven and unlicensed indication which needs to be more thoroughly evaluated.

The key objective of the study is to determine if 12 weeks treatment of patients with chronic productive cough with low dose azithromycin is both effective and safe.

The secondary objectives of the study are to describe the clinical and pathological features of a cohort of patients who present with chronic productive cough (with no evidence of bronchiectasis, smoking-related chronic bronchitis or immunodeficiency) to determine if these are sufficiently similar to justify a new diagnostic label.

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196493


Contacts
Contact: Matthew Martin, MBChB 01158231935 matthew.martin@nottingham.ac.uk

Locations
United Kingdom
Respiratory Research Unit Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Matthew Martin, MBChB    01158231935      
Principal Investigator: Tim Harrison, MD, FRCP         
Sub-Investigator: Matthew Martin, MBChB MRCP         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Tim Harrison, MD, FRCP University of Nottingham
  More Information

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02196493     History of Changes
Other Study ID Numbers: 13031
2013-002938-20 ( EudraCT Number )
First Submitted: July 10, 2014
First Posted: July 22, 2014
Last Update Posted: February 18, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Nottingham:
Productive
Cough
Bronchitis
Azithromycin

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms