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COPDCOLUMBUSNCT00985244

Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease

A study testing Azithromycin in people with COPD, run by R.S. Djamin at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COPD
What is being tested?
Azithromycin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteNetherlands
Study dates
May 2010to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Amphia Ziekenhuis

    Breda, North Brabant, 4818 CK

Other trials in Netherlands

About this study

Official title: Influence of Macrolide Maintenance Therapy and Bacterial Colonisation on Exacerbation Frequency and Progression of COPD, a Randomized Double-blind Placebo-controlled Trial

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.

Read the 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.

Conditions
COPD
Being tested
Azithromycin, Placebo
Keywords
COPD, COPD exacerbation, macrolide, diseae progression, bacterial colonisation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    Also called Zithromax, Azitrocin, Ultreon, Azadose

    Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.

  • PlaceboDrug

    Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.

Study groups in NCT00985244
Study groupRoleWhat they receive
AzithromycinActive comparatorSubjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin
Receives: Drug: Azithromycin
PlaceboPlacebo comparatorSubjects in this group will receive 3 times a week placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in number of exacerbations

    Measured: 1 year

Secondary outcomes (14)

  1. Lung function parameters (FEV1 (L), FVC (L), FRC (L), RV (L), TLC(L), IC (L), 6 minute walking distance)

    Measured: Day 1. Also 3, 6, 9 and 12 months.

  2. Disease specific health related quality of life measured by St. George's Respiratory Questionnaire (SGRQ)

    Measured: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation.

  3. Indication of anxiety and depression by Hospital Anxiety Depression Scale (HADS)

    Measured: Day 1. Also 3, 6, 9 and 12 months.

  4. Microbiology of sputum (culture and PCR).

    Measured: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.

  5. Measurement of inflammatory markers in sputum and serum.

    Measured: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.

  6. Adverse events of treatment.

    Measured: Day 1. Also 3, 6, 9 and 12 months. Whenever adverse events occur.

  7. Length of hospital stay.

    Measured: Whenever admission to hospital is required for an exacerbation of COPD.

  8. Time till next exacerbation.

    Measured: Whenever an exacerbation of COPD occurs.

  9. Assess type D personality by DS-14 questionnaire.

    Measured: Day 1 and month 12.

  10. Generic health status measured by 12-Item Short Form Health Survey (SF-12).

    Measured: Day 1, month 3, 6, 9 and 12. In case of an exacerbation.

  11. Decrease in percentage of clinical versus outdoor department exacerbations.

    Measured: Month 12.

  12. Effect of maintenance macrolides on intestinal bacterial restistancy patterns

    Measured: Day 1, month 6 and month 12

  13. Serology and PCR for atypical microorganisms in serum

    Measured: day 1. In case of an exacerbation.

  14. Intestinal bacterial resistance patterns

    Rectal swabs will be tested for bacterial resistance patterns and change in rectal flora as a result of maintenance azithromycin.

    Measured: Day 1, month 6 and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2009 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00985244
Sponsor's protocol ID
Amphia-ABR29500
Other IDs
2009-015857-19, 2009
Acronym
COLUMBUS
Status last verified
Jun 2013
First submitted
25 Sep 2009
Last updated
26 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Djamin RS, Talman S, Schrauwen EJA, von Wintersdorff CJH, Wolffs PF, Savelkoul PHM, Uzun S, Kerstens R, van der Eerden MM, Kluytmans JAJW. Prevalence and abundance of selected genes conferring macrolide resistance genes in COPD patients during maintenance treatment with azithromycin. Antimicrob Resist Infect Control. 2020 Jul 28;9(1):116. doi: 10.1186/s13756-020-00783-w.

    PubMed 32723393

  • Uzun S, Djamin RS, Kluytmans JA, Mulder PG, van't Veer NE, Ermens AA, Pelle AJ, Hoogsteden HC, Aerts JG, van der Eerden MM. Azithromycin maintenance treatment in patients with frequent exacerbations of chronic obstructive pulmonary disease (COLUMBUS): a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2014 May;2(5):361-8. doi: 10.1016/S2213-2600(14)70019-0. Epub 2014 Apr 15.

    PubMed 24746000

  • Uzun S, Djamin RS, Kluytmans J, Van't Veer NE, Ermens AA, Pelle AJ, Mulder P, van der Eerden MM, Aerts J. Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): study protocol for a randomised controlled trial. Trials. 2012 Jun 9;13:82. doi: 10.1186/1745-6215-13-82.

    PubMed 22682323

Questions about this trial

What is this clinical trial studying?

A study testing Azithromycin in people with COPD, run by R.S. Djamin at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in number of exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985244, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.

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