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Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease (COLUMBUS)

25. juni 2013 opdateret af: R.S. Djamin

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

92

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
    • Noord-Brabant
      • Breda, Noord-Brabant, Holland, 4818 CK
        • Amphia Ziekenhuis

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Azithromycin
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin
Medicin: Azithromycin
Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.
Andre navne:
  • Zithromax
  • Sumamed
  • Azitrocin
  • Ultreon
  • Azadose
  • Azacleus
  • Nuzaca
  • Toraseptol
  • Vinzam
  • Zentavion
Placebo komparator: Placebo
Subjects in this group will receive 3 times a week placebo
Medicin: Placebo
Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Reduction in number of exacerbations
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lung function parameters (FEV1 (L), FVC (L), FRC (L), RV (L), TLC(L), IC (L), 6 minute walking distance)
Tidsramme: Day 1. Also 3, 6, 9 and 12 months.
Day 1. Also 3, 6, 9 and 12 months.
Disease specific health related quality of life measured by St. George's Respiratory Questionnaire (SGRQ)
Tidsramme: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation.
Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation.
Indication of anxiety and depression by Hospital Anxiety Depression Scale (HADS)
Tidsramme: Day 1. Also 3, 6, 9 and 12 months.
Day 1. Also 3, 6, 9 and 12 months.
Microbiology of sputum (culture and PCR).
Tidsramme: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.
Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.
Measurement of inflammatory markers in sputum and serum.
Tidsramme: Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.
Day 1. Also 3, 6, 9 and 12 months. In case of an exacerbation of COPD.
Adverse events of treatment.
Tidsramme: Day 1. Also 3, 6, 9 and 12 months. Whenever adverse events occur.
Day 1. Also 3, 6, 9 and 12 months. Whenever adverse events occur.
Length of hospital stay.
Tidsramme: Whenever admission to hospital is required for an exacerbation of COPD.
Whenever admission to hospital is required for an exacerbation of COPD.
Time till next exacerbation.
Tidsramme: Whenever an exacerbation of COPD occurs.
Whenever an exacerbation of COPD occurs.
Assess type D personality by DS-14 questionnaire.
Tidsramme: Day 1 and month 12.
Day 1 and month 12.
Generic health status measured by 12-Item Short Form Health Survey (SF-12).
Tidsramme: Day 1, month 3, 6, 9 and 12. In case of an exacerbation.
Day 1, month 3, 6, 9 and 12. In case of an exacerbation.
Decrease in percentage of clinical versus outdoor department exacerbations.
Tidsramme: Month 12.
Month 12.
Effect of maintenance macrolides on intestinal bacterial restistancy patterns
Tidsramme: Day 1, month 6 and month 12
Day 1, month 6 and month 12
Serology and PCR for atypical microorganisms in serum
Tidsramme: day 1. In case of an exacerbation.
day 1. In case of an exacerbation.
Intestinal bacterial resistance patterns
Tidsramme: Day 1, month 6 and month 12
Rectal swabs will be tested for bacterial resistance patterns and change in rectal flora as a result of maintenance azithromycin.
Day 1, month 6 and month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

R.S. Djamin

Samarbejdspartnere

Erasmus Medical Center
Amphia Hospital
Stichting Solong

Efterforskere

  • Studieleder: Joachim Aerts, MD, PhD, Amphia Ziekenhuis
  • Studieleder: Menno van der Eerdem, MD, PhD, Erasmus Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

25. september 2009

Først indsendt, der opfyldte QC-kriterier

25. september 2009

Først opslået (Skøn)

28. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Amphia-ABR29500
  • 2009-015857-19 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med KOL

Kliniske forsøg med Azithromycin

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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