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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT01071161
First received: February 17, 2010
Last updated: April 5, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • Mean change in the Leicester Cough Questionnaire (LCQ) scores. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071161

Locations
Netherlands
Isala Klinieken
Zwolle, Gelderland, Netherlands, 8011 JW
Sponsors and Collaborators
Isala Klinieken
Investigators
Study Director: Jan Willem van den Berg, MD Department of Pulmonology
  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 July 10, 2014