The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of azithromycin to produce a significant change in the cough-related health status, measured with the Dutch version of the Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic productive coughing.

Detailed Description
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This study is a prospective double-centre, double blind randomised trial. Patients > 40 years of age, referred to our outpatient clinic with chronic cough and sputum production due to COPD will be recruited after informed consent is obtained. Consenting patients will be randomises to a 12-week treatment with 250 mg azithromycin three times a week or placebo. Before randomisation all patients have to fill in the SF 36 , SGRQ and the Dutch version of the Leicester Cough Questionnaire (LCQ) for assessment of the baseline quality of life and the disease specific quality of life. The LCQ questionnaires will be performed at the beginning and every 3 weeks afterwards until 18 weeks, except the second LCQ which will be filled in after 2 weeks. Scores from this questionnaire will be used to calculate the 2-week repeatability. The SF 36 and SGRQ will be performed at the start of the study and after 12 weeks. Adverse events will be recorded during the whole treatment period. After 2 and 12 weeks a Global Rating of Change will be performed. This questionnaire will be used to validate the LCQ in COPD patients. Randomisation will take place using a computer allocation program (BAMI-computer) Azithromycin and placebo will be provided by Teva Pharmaceuticals. Placebo and azithromycin will be identical in appearance and packaging.

Official Title
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Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough

Conditions
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Cough, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis

Intervention / Treatment
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* Drug: azithromycin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 40 years of age, in our outpatient clinic with chronic cough and COPD (gold2-4) Chronic cough is defined as a cough > 12 weeks duration, at least 12 weeks a year in 2 subsequent years. Analysed for bronchiectasis prior to participation by CT-thorax. Exclusion Criteria: Prior history of asthma Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion Patients suffering from other relevant lung diseases. Clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation. Liver disease, (ALAT and/or ASAT levels two or more times the upper limit of normal). Pregnancy or lactation. Use of macrolides the last 6 weeks prior to inclusion. Allergy or intolerance to macrolides. Other research medication started 2 months prior to inclusion. Prior randomisation in this study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin<br> | Drug: azithromycin<br>* azithromycin, tablets, during 12 weeks, three times a week, 250mg<br>* Other names: Zithromax;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the Leicester Cough Questionnaire (LCQ) scores. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the SF 36 and SGRQ scores. |  | 2 years | 
| Change in lung function, (FEV1 (L) and FVC (L)). |  | 2 years | 
| Number of exacerbations. |  | 2 years | 
| Adverse reactions. |  | 2 years | 
| Laboratory values: CRP, ASAT, ALAT |  | 2 years | 
| Sputum analysis |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic cough, COPD, Azithromycin, Zithromax, LCQ