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Tiotropium In Exercise

NCT ID: NCT00525512

Last Updated: 2013-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

519 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Brief Summary

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The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Exercise

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 18mcg

Oral inhalation once daily of 18mcg tiotropium via handihaler

Group Type EXPERIMENTAL

tiotropium 18 mcg

Intervention Type DRUG

Oral inhalation once daily of 18mcg tiotropium via handihaler

Placebo

Oral inhalation once daily of placebo matching tiotropium via handihaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Interventions

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tiotropium 18 mcg

Oral inhalation once daily of 18mcg tiotropium via handihaler

Intervention Type DRUG

Placebo

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All patients must sign an informed consent
2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)
3. Age \>= 40 years
4. Medical Research Council Dyspnoea score \>= 2
5. Current or ex-smoker with a \>= 10 pack-year smoking history
6. Ability to exercise on treadmill

Exclusion Criteria

1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
2. Clinical history of asthma
3. Use of supplemental oxygen therapy
4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
5. Recent history (\<= 12 months) of myocardial infarction
6. Unstable or life-threatening cardiac arrhythmia
7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years
8. Pregnant or nursing women
9. Known hypersensitivity to anticholinergic drugs or any component of the study medications
10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
11. Estimated life expectancy \< 2 years
12. Symptomatic prostatic hyperplasia or bladder neck obstruction
13. Known narrow-angle glaucoma
14. Any condition that is contraindicated for exercise
15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
16. Body mass index \< 18 kg/m2 or \>35 kg/m2 list truncated for space
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.368.01023 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

205.368.01022 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

205.368.01003 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

205.368.01008 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

205.368.01017 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Site Status

205.368.01028 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

205.368.01004 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Site Status

205.368.01013 Boehringer Ingelheim Investigational Site

North Miami Beach, Florida, United States

Site Status

205.368.01025 Boehringer Ingelheim Investigational Site

Hazard, Kentucky, United States

Site Status

205.368.01029 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

Site Status

205.368.01016 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

205.368.01002 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

205.368.01021 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

205.368.01014 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Site Status

205.368.01030 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Site Status

205.368.01018 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

205.368.01027 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Site Status

205.368.01019 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

205.368.01020 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

205.368.01024 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

205.368.01015 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

205.368.54001 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

Site Status

205.368.54002 Boehringer Ingelheim Investigational Site

Vicente López, , Argentina

Site Status

205.368.55003 Boehringer Ingelheim Investigational Site

Goiânia, , Brazil

Site Status

205.368.55004 Boehringer Ingelheim Investigational Site

Porto Alegre - RS, , Brazil

Site Status

205.368.55002 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

205.368.07006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

205.368.07001 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

205.368.07003 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

205.368.07004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

205.368.07005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

205.368.07008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

205.368.49005 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

205.368.49003 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

205.368.49004 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, , Germany

Site Status

205.368.49006 Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

205.368.49002 Boehringer Ingelheim Investigational Site

Schmallenberg, , Germany

Site Status

205.368.49001 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Site Status

205.368.39006 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

205.368.39004 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

205.368.39002 Boehringer Ingelheim Investigational Site

Parma, , Italy

Site Status

205.368.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

205.368.35103 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

205.368.35102 Boehringer Ingelheim Investigational Site

Matosinhos Municipality, , Portugal

Site Status

205.368.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.368.70004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.368.70005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.368.70006 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.368.70007 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

205.368.34005 Hospital Germans Trias i Pujol

Badalona (Barcelona), , Spain

Site Status

205.368.34002 Hospital de Cruces

Barakaldo (Bilbao), , Spain

Site Status

205.368.34001 Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status

205.368.34003 Hospital Gregorio Maranon

Madrid, , Spain

Site Status

205.368.34004 Hospital Universitario Vírgen del Rocío

Seville, , Spain

Site Status

205.368.34006 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

205.368.88604 Boehringer Ingelheim Investigational Site

Keelung, , Taiwan

Site Status

205.368.88602 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

205.368.88603 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

205.368.88601 Chang Gung Memorial Hosp-Linkou

Taoyuan District, , Taiwan

Site Status

205.368.38003 Boehringer Ingelheim Investigational Site

Dnyepropyetrovsk, , Ukraine

Site Status

205.368.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

205.368.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

Countries

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Austria Poland United States Argentina Brazil Canada Germany Italy Portugal Russia Spain Taiwan Ukraine

References

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Cooper CB, Celli BR, Jardim JR, Wise RA, Legg D, Guo J, Kesten S. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613.

Reference Type DERIVED
PMID: 23558890 (View on PubMed)

Other Identifiers

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2006-004610-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.368

Identifier Type: -

Identifier Source: org_study_id