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

Sponsor

Isala (Other)

Overall Status

Completed

CT.gov ID

NCT01071161

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cough Chronic Obstructive Pulmonary Disease Chronic Bronchitis	Drug: azithromycin Drug: placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azithromycin	Drug: azithromycin azithromycin, tablets, during 12 weeks, three times a week, 250mg Other Names: Zithromax
Placebo Comparator: Placebo	Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: Azithromycin

Drug: azithromycin

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

Other Names:

Zithromax

Placebo Comparator: Placebo

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

Mean change in the Leicester Cough Questionnaire (LCQ) scores. [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.