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Tiotropium / Respimat One Year Study in COPD. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Tiotropium / Respimat One Year Study in COPD.

Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

NCT00387088•Boehringer Ingelheim

Summary

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female
•2. At least 40 years old
•3. Smoker or ex-smoker
•4. Smoking history \> 10 pack-years
•5. Forced Expiratory Volume in 1 Second (FEV1) \< 60% predicted

Exclusion Criteria

•1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
•2. History of asthma or allergic conditions.
•3. Malignancy requiring treatment within past 5 years
•4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
•5. Known active tuberculosis
•6. Known hypersensitivity to anticholinergic drugs.

Locations (334)

205.372.01012 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

205.372.01020 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

205.372.01062 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

205.372.01048 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

205.372.01037 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

205.372.01058 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

205.372.01059 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

205.372.01007 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

205.372.01034 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

205.372.01028 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

Key Dates

Start Date

September 1, 2006

Primary Completion Date

January 1, 2009

Last Updated

May 16, 2014

Enrollment

3,991

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respimat

DEVICE

Tiotropium

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tiotropium / Respimat One Year Study in COPD.

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

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