High Dose Trial in COPD | NCT00128440

Studies
High Dose Trial in COPD

NCT00128440

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Oct 29, 2013Estimated

Enrollment

78Actual

Phase

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BEA 2180 BR
tiotropium

Countries

United States

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

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Not provided

First Submitted Date

Aug 9, 2005

First Submission Date that Met QC Criteria

Aug 9, 2005

First Posted Date

Aug 10, 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

Oct 28, 2013

Last Update Posted Date

Oct 29, 2013Estimated

Description Module

Brief Summary

The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.

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

78Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough forced expiratory volume (FEV1) response		baseline to 24 hours post drug administration
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.		after 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Trough FVC response after 4 weeks		after 4 weeks
FEV1 and FVC peak response after 0 and 4 weeks		after 0 and 4 weeks
FVC AUC0-6h after 0 and 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
Male or female patients 40 years of age or older.
Smoker or ex-smoker with a history of more than 10 pack years.

1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boehringer Ingelheim Study Coordinator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Lakewood	California		United States
Boehringer Ingelheim Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

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
D000069447	Tiotropium Bromide

Ancestor Terms

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided