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Tiotropium / Respimat One-Year Study

NCT ID: NCT00168844

Last Updated: 2014-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

983 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

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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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

Los Angeles, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Pismo Beach, California, United States

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Boehringer Ingelheim Investigational Site

San Diego, California, United States

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Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

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Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

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Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

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Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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Chattanooga, Tennessee, United States

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Harker Heights, Texas, United States

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Houston, Texas, United States

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Fredericksburg, Virginia, United States

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Harrisonburg, Virginia, United States

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Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

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Woodville, South Australia, Australia

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Clayton, Victoria, Australia

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Frankston, Victoria, Australia

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Perth, Western Australia, Australia

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Antwerp, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Wavre, , Belgium

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Edmonton, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Courtice, Ontario, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Angers, , France

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Beuvry, , France

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Cambrai, , France

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Lille, , France

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Metz, , France

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Berlin, , Germany

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Darmstadt, , Germany

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Gelnhausen, , Germany

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Kassel, , Germany

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Rüdersdorf, , Germany

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Athens, , Greece

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Heraklion, , Greece

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Larissa, , Greece

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Maroussi, Athens, , Greece

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Melissia-Athens, , Greece

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Breda, , Netherlands

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Dordrecht, , Netherlands

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Groningen, , Netherlands

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Harderwijk, , Netherlands

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Heerlen, , Netherlands

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Zutphen, , Netherlands

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Ålesund, , Norway

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Oslo, , Norway

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Trondheim, , Norway

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Moscow, , Russia

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Alicante, , Spain

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Las Palmas de Gran Canaria, , Spain

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Madrid, , Spain

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Vic (Barcelona), , Spain

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Motala, , Sweden

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Skövde, , Sweden

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Uppsala, , Sweden

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Varberg, , Sweden

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Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

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Boehringer Ingelheim Investigational Site

Bursa, , Turkey (Türkiye)

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Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

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Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

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Boehringer Ingelheim Investigational Site

Bristol, , United Kingdom

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Boehringer Ingelheim Investigational Site

Nottingham, , United Kingdom

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Boehringer Ingelheim Investigational Site

Sheffield, , United Kingdom

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Boehringer Ingelheim Investigational Site

Swansea, , United Kingdom

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Boehringer Ingelheim Investigational Site

Torquay, , United Kingdom

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Countries

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United States Australia Belgium Canada France Germany Greece Netherlands Norway Russia Spain Sweden Turkey (Türkiye) 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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205.254

Identifier Type: -

Identifier Source: org_study_id

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