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

September 17, 2015 updated by: Jan W.K. van den Berg, Isala

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Ov
      • Zwolle, Ov, Netherlands, 8011 JW
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: placebo
placebo
EXPERIMENTAL: Azithromycin
Drug: azithromycin
azithromycin, tablets, during 12 weeks, three times a week, 250mg
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in the Leicester Cough Questionnaire (LCQ) scores.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in the SF 36 and SGRQ scores.
Time Frame: 2 years
2 years
Change in lung function, (FEV1 (L) and FVC (L)).
Time Frame: 2 years
2 years
Number of exacerbations.
Time Frame: 2 years
2 years
Adverse reactions.
Time Frame: 2 years
2 years
Laboratory values: CRP, ASAT, ALAT
Time Frame: 2 years
2 years
Sputum analysis
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Investigators

  • Study Director: Jan W van den Berg, MD, Department of Pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (ESTIMATE)

February 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL19886.075.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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