12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Re... | NCT00239473

Studies
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

NCT00239473

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Nov 1, 2013Estimated

Enrollment

429

Phase

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Countries

Germany
Italy
South Africa
Switzerland

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

Official Title

A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Start Date

Nov 2002

Primary Completion Date

Dec 2003Actual

Completion Date

Not provided

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Oct 14, 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

Oct 31, 2013

Last Update Posted Date

Nov 1, 2013Estimated

Description Module

Brief Summary

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

429

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler	Device
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough FEV1 response		after 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Trough FEV1 response		after 1, 4 and 8 weeks
Trough FVC response		after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve (AUC)0-6h and peak response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 \

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
Boehringer Ingelheim Study Coordinator	Boehringer Ingelheim	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Berlin			Germany
MEDARS GmbH

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms