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Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease (COLUMBUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Erasmus Medical Center
Stichting Solong
Information provided by:
Amphia Hospital
ClinicalTrials.gov Identifier:
NCT00985244
First received: September 25, 2009
Last updated: July 9, 2012
Last verified: May 2010
History of Changes
  Purpose

To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.


Condition Intervention
COPD
 Drug: Azithromycin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Macrolide Maintenance Therapy and Bacterial Colonisation on Exacerbation Frequency and Progression of COPD, a Randomized Double-blind Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amphia Hospital:

Primary Outcome Measures:
  • Reduction in number of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function parameters (FEV1 (L), FVC (L), FRC (L), RV (L), TLC(L), IC (L), 6 minute walking distance) [ Time Frame: Day 1. Also 3, 6, 9 and 12 months. ] [ Designated as safety issue: No ]
  • Disease specific health related quality of life measured by St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation. ] [ Designated as safety issue: No ]
  • Indication of anxiety and depression by Hospital Anxiety Depression Scale (HADS) [ Time Frame: Day 1. Also 3, 6, 9 and 12 months. ] [ Designated as safety issue: No ]
  • Microbiology of sputum (culture and PCR). [ Time Frame: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD. ] [ Designated as safety issue: No ]
  • Measurement of inflammatory markers in sputum and serum. [ Time Frame: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD. ] [ Designated as safety issue: No ]
  • Adverse events of treatment. [ Time Frame: Day 1. Also 3, 6, 9 and 12 months. Whenever adverse events occur. ] [ Designated as safety issue: Yes ]
  • Length of hospital stay. [ Time Frame: Whenever admission to hospital is required for an exacerbation of COPD. ] [ Designated as safety issue: No ]
  • Time till next exacerbation. [ Time Frame: Whenever an exacerbation of COPD occurs. ] [ Designated as safety issue: No ]
  • Assess type D personality by DS-14 questionnaire. [ Time Frame: Day 1 and month 12. ] [ Designated as safety issue: No ]
  • Generic health status measured by 12-Item Short Form Health Survey (SF-12). [ Time Frame: Day 1, month 3, 6, 9 and 12. In case of an exacerbation. ] [ Designated as safety issue: No ]
  • Decrease in percentage of clinical versus outdoor department exacerbations. [ Time Frame: Month 12. ] [ Designated as safety issue: No ]
  • Effect of maintenance macrolides on intestinal bacterial restistancy patterns [ Time Frame: Day 1, month 6 and month 12 ] [ Designated as safety issue: No ]
  • Serology and PCR for atypical microorganisms in serum [ Time Frame: day 1. In case of an exacerbation. ] [ Designated as safety issue: No ]
  • Intestinal bacterial resistance patterns [ Time Frame: Day 1, month 6 and month 12 ] [ Designated as safety issue: No ]
    Rectal swabs will be tested for bacterial resistance patterns and change in rectal flora as a result of maintenance azithromycin.


Estimated Enrollment: 92
Study Start Date: May 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azithromycin
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin
 Drug: Azithromycin
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.
Other Names:
  • Zithromax
  • Azitrocin
  • Ultreon
  • Azadose
  • Sumamed
  • Azacleus
  • Nuzaca
  • Toraseptol
  • Vinzam
  • Zentavion
Placebo Comparator: Placebo
Subjects in this group will receive 3 times a week placebo
 Drug: Placebo
Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.

Detailed Description:

COPD is characterized by progressive development of airflow limitation that is poorly reversible. Because of a poor understanding of COPD pathogenesis, treatment is mostly symptomatic and new therapeutic strategies are limited. There is a direct relationship between the severity of the disease and the intensity of the inflammatory response.One of the hypothesis for persistent airway inflammation is that the presence of recurrent infections is responsible for this condition.

Macrolide antibiotics have a bacteriostatic as well as anti-inflammatory properties. This clinical trial will investigate whether maintenance treatment with macrolide antibiotics during 1 year in people with 3 or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in that same year of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD according to GOLD criteria (FEV1/FVC<70%), classification into GOLD I (FEV1 70-100% predicted), GOLD II (FEV1 50-70% predicted), GOLD III (FEV1 30- 50% predicted) or GOLD IV (FEV1 ≤ 30% predicted)
  • Age ≥ 18 years
  • Three or more exacerbations of COPD in one year for which a course of prednisone and/or antibiotic therapy was started
  • Clinically stable during 1 month. Patients have to be free of COPD exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period
  • Informed consent

Exclusion Criteria:

  • Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study.
  • Addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study.
  • Pregnant or lactating women.
  • Allergy to macrolides.
  • Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
  • Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing.
  • Presence of a malignancy which is clinically active.
  • Bronchiectasis.
  • Malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment.
  • Heart failure.
  • Use of drugs which can adversely interact with macrolides and for which therapeutic monitoring cannot be undertaken.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985244

Locations
Netherlands
Amphia Ziekenhuis
Breda, Noord-Brabant, Netherlands, 4818 CK
Sponsors and Collaborators
Amphia Hospital
Erasmus Medical Center
Stichting Solong
Investigators
Study Director: Joachim Aerts, MD, PhD Amphia Ziekenhuis
Study Director: Menno van der Eerdem, MD, PhD Erasmus MC
  More Information

No publications provided by Amphia Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: drs. R.S. Djamin, Amphia Ziekenhuis
ClinicalTrials.gov Identifier: NCT00985244     History of Changes
Other Study ID Numbers: Amphia-ABR29500, 2009-015857-19
Study First Received: September 25, 2009
Last Updated: July 9, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Amphia Hospital:
COPD
COPD exacerbation
macrolide
diseae progression
bacterial colonisation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Azithromycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013