Antibiotics in Chronic Obstructive Pulmonary Disease (COPD) | NCT00952861

Studies
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)

NCT00952861

Sponsor

Odense University Hospital

Status

Withdrawn

Last Update Posted

Aug 11, 2010Estimated

Enrollment

140Estimated

Phase

Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Doxycycline
Placebo (matching)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped due to poor recruitment

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2010

Last Update Posted Date

Aug 11, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Name	Class
Kolding Sygehus	OTHER
Svendborg Hospital	OTHER
Fredericia Hospital	UNKNOWN
Naestved Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doxycycline	Active Comparator	Doxycycline 200 mg QD in 5 days	Drug: Doxycycline
Placebo	Placebo Comparator	Matching placebo QD i 5 days	Drug: Placebo (matching)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxycycline	Drug	200 mg QD in 5 days	Doxycycline
Placebo (matching)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6 minutes walking distance		Day 14

Secondary Outcomes

Measure	Description	Time Frame
Time to next episode of acute exacerbation		Days 14, 30, 90 and 180

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 50 years
History of smoking
History of COPD
Antibiotics for 24 hours
At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
Informed consent

Exclusion Criteria:

Pneumonia
Antibiotics for more than 36 hours
Antibiotics for other infection
Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
Malignancy
Other pulmonary disease
Immune deficiency
Not able to tolerate doxycycline
Severe heart, liver or kidney disease
Epilepsia
Not stable 24 hours after hospital admission
Need for assisted ventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Court Pedersen, MD	Odense University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D007239	Infections

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004318	Doxycycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided