Trials Sponsors Conditions Drugs Pricing

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
at the end of each 4-week period

Secondary Outcomes (10)

Tiotropium plasma concentration data and urinary excretion data
at the end of each 4-week period
Trough forced vital capacity (FVC) response
after 4 weeks
Peak response (FEV1 and FVC)
within 3 hours after first dose, after 4 weeks
FEV1 AUC 0-12h and FVC AUC 0-12h response
after 4 weeks
FEV1 AUC 0-3h and FVC AUC 0-3h response
after the first dose, after 4 weeks
+5 more secondary outcomes

Interventions

TiotropiumDrug

HandiHalerDevice

Respimat SMIDevice

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All patients had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
All patients had to have a diagnosis of chronic obstructive pulmonary disease.

Sponsors & Collaborators

Boehringer Ingelheim
Industrylead

Study Sites (11)

Division of Pulmonary and Critical Care Medicine

Little Rock, Arkansas, 72205, United States

Boehringer Ingelheim Investigational Site

San Diego, California, 92120, United States

San Jose Clinical Research

San Jose, California, 95128, United States

Boehringer Ingelheim Investigational Site

Stockton, California, 95207, United States

National Jewish Medical and Research Center

Denver, Colorado, 80206-2762, United States

LSU MC-Sheveport

Shreveport, Louisiana, 71103, United States

Minisota Lung Center

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo Compounds

Study Officials

Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim BV/Alkmaar
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 17, 2005

Study Start

November 26, 2002

Actual (reported)

Primary Completion

April 29, 2004

Actual (reported)

Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations