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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01071161
Other study ID # NL19886.075.08
Secondary ID
Status Completed
Phase Phase 3
First received February 17, 2010
Last updated September 17, 2015
Start date September 2009
Est. completion date February 2012

Study information

Verified date September 2015
Source Isala
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
azithromycin
azithromycin, tablets, during 12 weeks, three times a week, 250mg
placebo
placebo

Locations

Country Name City State
Netherlands Isala Klinieken Zwolle Ov

Sponsors (1)

Lead Sponsor Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in the Leicester Cough Questionnaire (LCQ) scores. 2 years No
Secondary Mean change in the SF 36 and SGRQ scores. 2 years No
Secondary Change in lung function, (FEV1 (L) and FVC (L)). 2 years No
Secondary Number of exacerbations. 2 years No
Secondary Adverse reactions. 2 years No
Secondary Laboratory values: CRP, ASAT, ALAT 2 years No
Secondary Sputum analysis 2 years No
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