The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough (CACTUS)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cough Chronic Obstructive Pulmonary Disease Chronic Bronchitis |
Drug: azithromycin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 84 |
| Study Start Date: | September 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Azithromycin |
Drug: azithromycin
azithromycin, tablets, during 12 weeks, three times a week, 250mg
Other Name: Zithromax
|
| Placebo Comparator: Placebo |
Drug: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided by Isala Klinieken
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jan W.K. van den Berg, Dr., Isala Klinieken |
| ClinicalTrials.gov Identifier: | NCT01071161 History of Changes |
| Other Study ID Numbers: | NL19886.075.08 |
| Study First Received: | February 17, 2010 |
| Last Updated: | April 5, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Isala Klinieken:
|
chronic cough COPD Azithromycin Zithromax LCQ |
Additional relevant MeSH terms:
|
Bronchitis Bronchitis, Chronic Cough Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Signs and Symptoms, Respiratory Signs and Symptoms Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013