Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial
<p>Abstract</p> <p>Background</p> <p>Chronic obstructive pulmonary disease (COPD) is characterised by progressive development of airflow limitation that is poorly reversible. Because of a poor understanding of COPD pathogenesis, treatment is mostly symptomatic and new t...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2012-06-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://www.trialsjournal.com/content/13/1/82 |
| _version_ | 1818701615989784576 |
|---|---|
| author | Uzun Sevim Djamin Remco S Kluytmans JanAJW Van’t Veer Nils E Ermens Anton A M Pelle Aline J Mulder Paul van der Eerden Menno M Aerts JoachimGJV |
| author_facet | Uzun Sevim Djamin Remco S Kluytmans JanAJW Van’t Veer Nils E Ermens Anton A M Pelle Aline J Mulder Paul van der Eerden Menno M Aerts JoachimGJV |
| author_sort | Uzun Sevim |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Chronic obstructive pulmonary disease (COPD) is characterised 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. Besides smoking, one of the hypotheses for the persistent airway inflammation is the presence of recurrent infections. Macrolide antibiotics have bacteriostatic as well as anti-inflammatory properties in patients with cystic fibrosis and other inflammatory pulmonary diseases. There is consistent evidence that macrolide therapy reduces infectious exacerbations, decreases the requirement for additional antibiotics and improves nutritional measures. Because of these positive effects we hypothesised that maintenance macrolide therapy may also have beneficial effects in patients with COPD who have recurrent exacerbations. The effects on development of bacterial resistance to macrolides due to this long-term treatment are unknown. Until now, studies investigating macrolide therapy in COPD are limited. The objective of this study is to assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year decreases the exacerbation rate in the year of treatment and to establish microbial resistance due to the long-term treatment.</p> <p>Methods/design</p> <p>The study is set up as a prospective randomised double-blind placebo-controlled single-centre trial. A total of 92 patients with COPD who have had at least three exacerbations of COPD in the previous year will be included. Subjects will be randomised to receive either azithromycin 500 mg three times a week or placebo. Our primary endpoint is the reduction in the number of exacerbations of COPD in the year of treatment.</p> <p>Discussion</p> <p>We investigate whether long-term therapy with macrolide antibiotics can prevent exacerbations in patients with COPD. Additionally, our study aims to assess the effect of long-term use of macrolide on the development of antimicrobial resistance and on inflammatory parameters related to COPD. We believe this study will provide more data on the effects of macrolide treatment in patients in COPD and will add more knowledge on its working mechanisms.</p> <p>Trial registration</p> <p><url>http://www.clinicaltrials.gov</url> NCT00985244</p> |
| first_indexed | 2024-12-17T15:23:40Z |
| format | Article |
| id | doaj.art-0f65fe1771c642499634ebf22ade6782 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T15:23:40Z |
| publishDate | 2012-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-0f65fe1771c642499634ebf22ade67822022-12-21T21:43:19ZengBMCTrials1745-62152012-06-011318210.1186/1745-6215-13-82Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trialUzun SevimDjamin Remco SKluytmans JanAJWVan’t Veer Nils EErmens Anton A MPelle Aline JMulder Paulvan der Eerden Menno MAerts JoachimGJV<p>Abstract</p> <p>Background</p> <p>Chronic obstructive pulmonary disease (COPD) is characterised 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. Besides smoking, one of the hypotheses for the persistent airway inflammation is the presence of recurrent infections. Macrolide antibiotics have bacteriostatic as well as anti-inflammatory properties in patients with cystic fibrosis and other inflammatory pulmonary diseases. There is consistent evidence that macrolide therapy reduces infectious exacerbations, decreases the requirement for additional antibiotics and improves nutritional measures. Because of these positive effects we hypothesised that maintenance macrolide therapy may also have beneficial effects in patients with COPD who have recurrent exacerbations. The effects on development of bacterial resistance to macrolides due to this long-term treatment are unknown. Until now, studies investigating macrolide therapy in COPD are limited. The objective of this study is to assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year decreases the exacerbation rate in the year of treatment and to establish microbial resistance due to the long-term treatment.</p> <p>Methods/design</p> <p>The study is set up as a prospective randomised double-blind placebo-controlled single-centre trial. A total of 92 patients with COPD who have had at least three exacerbations of COPD in the previous year will be included. Subjects will be randomised to receive either azithromycin 500 mg three times a week or placebo. Our primary endpoint is the reduction in the number of exacerbations of COPD in the year of treatment.</p> <p>Discussion</p> <p>We investigate whether long-term therapy with macrolide antibiotics can prevent exacerbations in patients with COPD. Additionally, our study aims to assess the effect of long-term use of macrolide on the development of antimicrobial resistance and on inflammatory parameters related to COPD. We believe this study will provide more data on the effects of macrolide treatment in patients in COPD and will add more knowledge on its working mechanisms.</p> <p>Trial registration</p> <p><url>http://www.clinicaltrials.gov</url> NCT00985244</p>http://www.trialsjournal.com/content/13/1/82COPDCOPD exacerbationMacrolide antibioticsLong-term treatmentAntibiotic resistance |
| spellingShingle | Uzun Sevim Djamin Remco S Kluytmans JanAJW Van’t Veer Nils E Ermens Anton A M Pelle Aline J Mulder Paul van der Eerden Menno M Aerts JoachimGJV Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial Trials COPD COPD exacerbation Macrolide antibiotics Long-term treatment Antibiotic resistance |
| title | Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial |
| title_full | Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial |
| title_fullStr | Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial |
| title_full_unstemmed | Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial |
| title_short | Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial |
| title_sort | influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of copd columbus study protocol for a randomised controlled trial |
| topic | COPD COPD exacerbation Macrolide antibiotics Long-term treatment Antibiotic resistance |
| url | http://www.trialsjournal.com/content/13/1/82 |
| work_keys_str_mv | AT uzunsevim influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT djaminremcos influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT kluytmansjanajw influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT vantveernilse influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT ermensantonam influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT pellealinej influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT mulderpaul influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT vandereerdenmennom influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial AT aertsjoachimgjv influenceofmacrolidemaintenancetherapyandbacterialcolonisationonexacerbationfrequencyandprogressionofcopdcolumbusstudyprotocolforarandomisedcontrolledtrial |