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

Chronic Obstructive Pulmonary Disease Clinical Trial

— CACTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071161
• Other study ID #: NL19886.075.08
• 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

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Cough
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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