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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. Identifier: NCT01071161
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : September 18, 2015
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala

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.

Condition or disease Intervention/treatment Phase
Cough Chronic Obstructive Pulmonary Disease Chronic Bronchitis Drug: azithromycin Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough
Study Start Date : September 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Azithromycin Drug: azithromycin
azithromycin, tablets, during 12 weeks, three times a week, 250mg
Other Name: Zithromax

Placebo Comparator: Placebo Drug: placebo

Primary Outcome Measures :
  1. Mean change in the Leicester Cough Questionnaire (LCQ) scores. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Mean change in the SF 36 and SGRQ scores. [ Time Frame: 2 years ]
  2. Change in lung function, (FEV1 (L) and FVC (L)). [ Time Frame: 2 years ]
  3. Number of exacerbations. [ Time Frame: 2 years ]
  4. Adverse reactions. [ Time Frame: 2 years ]
  5. Laboratory values: CRP, ASAT, ALAT [ Time Frame: 2 years ]
  6. Sputum analysis [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071161

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Isala Klinieken
Zwolle, Ov, Netherlands, 8011 JW
Sponsors and Collaborators
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Study Director: Jan W van den Berg, MD Department of Pulmonology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jan W.K. van den Berg, Dr., Isala Identifier: NCT01071161    
Other Study ID Numbers: NL19886.075.08
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015
Keywords provided by Jan W.K. van den Berg, Isala:
chronic cough
Additional relevant MeSH terms:
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Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Respiratory Tract Infections
Bronchial Diseases
Anti-Bacterial Agents
Anti-Infective Agents