Budesonide / Formoterol in Treatment of Exacerbations of... | NCT00239278

Studies
Budesonide / Formoterol in Treatment of Exacerbations of COPD

NCT00239278

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 24, 2011Estimated

Enrollment

120

Phase

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

budesonide/formoterol, 2x 200/6 microgram. 4 times daily
prednisolone, 30 mg once daily and placebo

Countries

Netherlands

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

ID	Type	Description	Link
D5892C00698	Other Identifier	AstraZeneca

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Not provided

Completion Date

Jan 2005Actual

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 17, 2005Estimated

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

Jan 21, 2011

Last Update Posted Date

Jan 24, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
budesonide/formoterol, 2x 200/6 microgram. 4 times daily	Drug			Symbicort
prednisolone, 30 mg once daily and placebo	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory markers in induced sputum, blood/serum and urine
Lung function tests at clinic
Diary cards for PEF and symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

smoking-induced COPD according to ATS criteria
FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation
FEV1/IVC ratio <88% of predicted for men and <89% for women

Exclusion Criteria:

history of asthma
known hypersensitivity to the study drugs
serious concomitant diseases
pregnancy or lactating
abnormal Chest X-ray or blood gasses

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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
AstraZeneca Netherlands Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Groningen			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18972276	Derived	Bathoorn E, Liesker JJ, Postma DS, Boorsma M, Bondesson E, Koeter GH, Kauffman HF, van Oosterhout AJ, Kerstjens HA. Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations. COPD. 2008 Oct;5(5):282-90. doi: 10.1080/15412550802363360.
17296644	Derived	Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8. doi: 10.1378/chest.06-2216.

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

ID	Term
D019819	Budesonide
D000068759	Formoterol Fumarate
D000069502	Budesonide, Formoterol Fumarate Drug Combination
D011239	Prednisolone

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473