NCT00170222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

6.1 years

First QC Date

September 9, 2005

Last Update Submit

September 26, 2008

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Acute bronchitisantibiotics

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy at the end of treatment

Secondary Outcomes (2)

  • Treatment failure at follow up

  • Number of exacerbation

Interventions

doxycyclineDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute exacerbation of COPD type I or II according to GOLD
  • Ability to perform lung function tests
  • Ability to take oral medication

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch centrum Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 20576731DERIVED

  • 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.

    PMID: 19875685DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Johannes MA Daniels, drs

    Pulmo Science

    PRINCIPAL INVESTIGATOR

  • Dominic Snijders, drs

    Pulmo Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

July 1, 2002

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

NL(1)