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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071161
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date September 18, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
Mean change in the Leicester Cough Questionnaire (LCQ) scores. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • Mean change in the SF 36 and SGRQ scores. [ Time Frame: 2 years ]
  • Change in lung function, (FEV1 (L) and FVC (L)). [ Time Frame: 2 years ]
  • Number of exacerbations. [ Time Frame: 2 years ]
  • Adverse reactions. [ Time Frame: 2 years ]
  • Laboratory values: CRP, ASAT, ALAT [ Time Frame: 2 years ]
  • Sputum analysis [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough
Official Title  ICMJE Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cough
  • Chronic Obstructive Pulmonary Disease
  • Chronic Bronchitis
Intervention  ICMJE
  • Drug: azithromycin
    azithromycin, tablets, during 12 weeks, three times a week, 250mg
    Other Name: Zithromax
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: Azithromycin
    Intervention: Drug: azithromycin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
84
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071161
Other Study ID Numbers  ICMJE NL19886.075.08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan W.K. van den Berg, Isala
Study Sponsor  ICMJE Isala
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jan W van den Berg, MD Department of Pulmonology
PRS Account Isala
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP