Clinical trial NCT00170222: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acute bronchitis
antibiotics
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 258
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Clinical efficacy at the end of treatment
Secondary outcomes:
measure: Treatment failure at follow up
measure: Number of exacerbation
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch centrum Alkmaar
state: Noord-holland
Study officials:
affiliation: Pulmo Science
name: Johannes MA Daniels, drs
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmo Science
name: Dominic Snijders, drs
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.