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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Acute bronchitis antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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doxycycline

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Johannes MA Daniels, drs

Role: PRINCIPAL_INVESTIGATOR

Pulmo Science

Dominic Snijders, drs

Role: PRINCIPAL_INVESTIGATOR

Pulmo Science

Locations

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Medisch centrum Alkmaar

Alkmaar, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED

PMID: 20576731 (View on PubMed)

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.