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Tiotropium / Respimat One-Year Study

NCT ID: NCT00168831

Last Updated: 2014-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1007 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Tiotropium Respimat 5mcg (Tio R5)

Group Type OTHER

Tiotropium Inhalation Solution

Intervention Type DRUG

Tiotropium Respimat 10mcg (Tio R10)

Group Type OTHER

Tiotropium Inhalation Solution

Intervention Type DRUG

Placebo

Group Type OTHER

Placebo

Intervention Type OTHER

Interventions

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Tiotropium Inhalation Solution

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Criteria * Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study.

Exclusion Criteria

Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

La Jolla, California, United States

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Boehringer Ingelheim Investigational Site

Long Beach, California, United States

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Boehringer Ingelheim Investigational Site

San Luis Obispo, California, United States

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Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

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Boehringer Ingelheim Investigational Site

Hallandale, Florida, United States

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Boehringer Ingelheim Investigational Site

Hines, Illinois, United States

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Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

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Boehringer Ingelheim Investigational Site

Bay Shore, New York, United States

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Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

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Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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Boehringer Ingelheim Investigational Site

Garran, Australian Capital Territory, Australia

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Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

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Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

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Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

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Boehringer Ingelheim Investigational Site

Mittersill, , Austria

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Boehringer Ingelheim Investigational Site

Schwechat, , Austria

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Baumgartner Hohe Otto Wagner Spital Wien

Vienna, , Austria

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Boehringer Ingelheim Investigational Site

Vienna, , Austria

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Boehringer Ingelheim Investigational Site

Wels, , Austria

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Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Espoo, , Finland

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Boehringer Ingelheim Investigational Site

Helsinki, , Finland

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Boehringer Ingelheim Investigational Site

Lahti, , Finland

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Boehringer Ingelheim Investigational Site

Lappeenranta, , Finland

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Lohja, , Finland

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Amboise, , France

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Chauny, , France

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Marseille, , France

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Metz, , France

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Montpellier, , France

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Nantes, , France

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Alexandroupoli, , Greece

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Athens, , Greece

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Mournies-Chania, , Greece

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Trikala, , Greece

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Dublin, , Ireland

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Bologna, , Italy

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Bussolengo (vr), , Italy

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Boehringer Ingelheim Investigational Site

Cava Dei Tirreni (SA), , Italy

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Boehringer Ingelheim Investigational Site

Crema (CR), , Italy

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Genova, , Italy

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Milan, , Italy

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Pistoia, , Italy

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Roma, , Italy

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Salerno, , Italy

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Boehringer Ingelheim Investigational Site

Sesto San Giovanni (Milano), , Italy

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Boehringer Ingelheim Investigational Site

Arnhem, , Netherlands

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Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

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Boehringer Ingelheim Investigational Site

Heerenveen, , Netherlands

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Boehringer Ingelheim Investigational Site

Hoorn, , Netherlands

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Boehringer Ingelheim Investigational Site

Leeuwarden, , Netherlands

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Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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Boehringer Ingelheim Investigational Site

Auckland, , New Zealand

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Boehringer Ingelheim Investigational Site

Hamilton, , New Zealand

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Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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Boehringer Ingelheim Investigational Site

Bellville, , South Africa

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Cape Town, , South Africa

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George, , South Africa

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Johannesburg, , South Africa

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Boehringer Ingelheim Investigational Site

Vanderbijlpark, , South Africa

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Boehringer Ingelheim Investigational Site

Barcelona, , Spain

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Boehringer Ingelheim Investigational Site

Centelles, , Spain

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Boehringer Ingelheim Investigational Site

Murcia, , Spain

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Boehringer Ingelheim Investigational Site

Sant Boi de Llobregat (Barcelona), , Spain

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Boehringer Ingelheim Investigational Site

Babbacombe, , United Kingdom

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Boehringer Ingelheim Investigational Site

Cottingham, , United Kingdom

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Boehringer Ingelheim Investigational Site

Isleworth, , United Kingdom

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Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

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Boehringer Ingelheim Investigational Site

Plymouth, , United Kingdom

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Boehringer Ingelheim Investigational Site

Sunderland, , United Kingdom

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Countries

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United States Australia Austria Canada Finland France Greece Ireland Italy Netherlands New Zealand Russia South Africa Spain United Kingdom

References

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Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

Reference Type DERIVED
PMID: 32943047 (View on PubMed)

Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.

Reference Type DERIVED
PMID: 25496316 (View on PubMed)

Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat(R) Soft Mist Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26.

Reference Type DERIVED
PMID: 21814460 (View on PubMed)

Other Identifiers

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205.255

Identifier Type: -

Identifier Source: org_study_id

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