The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough (CACTUS)
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.
Chronic Obstructive Pulmonary Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough|
- Mean change in the Leicester Cough Questionnaire (LCQ) scores. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Mean change in the SF 36 and SGRQ scores. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Change in lung function, (FEV1 (L) and FVC (L)). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of exacerbations. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Adverse reactions. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Laboratory values: CRP, ASAT, ALAT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Sputum analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
azithromycin, tablets, during 12 weeks, three times a week, 250mg
Other Name: Zithromax
|Placebo Comparator: Placebo||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071161
|Zwolle, Gelderland, Netherlands, 8011 JW|
|Study Director:||Jan Willem van den Berg, MD||Department of Pulmonology|