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Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
doxycycline
Sponsored by
Medical Center Alkmaar
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Acute bronchitis, antibiotics

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute exacerbation of COPD type I or II according to GOLD Ability to perform lung function tests Ability to take oral medication Exclusion Criteria: Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation. Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation. Progression or new radiographic abnormalities on the chest X-ray. Severe exacerbation that required mechanical ventilation. History of bronchiectasis Recent or unresolved lung malignancy. Other disease likely to require antibiotic therapy. Significant gastrointestinal or other conditions that may affect study drug absorption. Class III or IV congestive heart failure or stroke. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks). Cystic fibrosis Tuberculosis. Impaired renal function (creatinine clearance < 20 ml/min).

Sites / Locations

  • Medisch centrum Alkmaar

Outcomes

Primary Outcome Measures

Clinical efficacy at the end of treatment

Secondary Outcome Measures

Treatment failure at follow up
Number of exacerbation

Full Information

First Posted
September 9, 2005
Last Updated
September 26, 2008
Sponsor
Medical Center Alkmaar
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1. Study Identification

Unique Protocol Identification Number
NCT00170222
Brief Title
Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Official Title
The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Center Alkmaar

4. Oversight

5. Study Description

Brief Summary
The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized. The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Acute bronchitis, antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxycycline
Primary Outcome Measure Information:
Title
Clinical efficacy at the end of treatment
Secondary Outcome Measure Information:
Title
Treatment failure at follow up
Title
Number of exacerbation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute exacerbation of COPD type I or II according to GOLD Ability to perform lung function tests Ability to take oral medication Exclusion Criteria: Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation. Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation. Progression or new radiographic abnormalities on the chest X-ray. Severe exacerbation that required mechanical ventilation. History of bronchiectasis Recent or unresolved lung malignancy. Other disease likely to require antibiotic therapy. Significant gastrointestinal or other conditions that may affect study drug absorption. Class III or IV congestive heart failure or stroke. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks). Cystic fibrosis Tuberculosis. Impaired renal function (creatinine clearance < 20 ml/min).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes MA Daniels, drs
Organizational Affiliation
Pulmo Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominic Snijders, drs
Organizational Affiliation
Pulmo Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch centrum Alkmaar
City
Alkmaar
State/Province
Noord-holland
ZIP/Postal Code
1815 JD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20576731
Citation
Daniels JM, Schoorl M, Snijders D, Knol DL, Lutter R, Jansen HM, Boersma WG. Procalcitonin vs C-reactive protein as predictive markers of response to antibiotic therapy in acute exacerbations of COPD. Chest. 2010 Nov;138(5):1108-15. doi: 10.1378/chest.09-2927. Epub 2010 Jun 24.
Results Reference
derived
PubMed Identifier
19875685
Citation
Daniels JM, Snijders D, de Graaff CS, Vlaspolder F, Jansen HM, Boersma WG. Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Jan 15;181(2):150-7. doi: 10.1164/rccm.200906-0837OC. Epub 2009 Oct 29.
Results Reference
derived

Learn more about this trial

Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

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