Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2006-10-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Tiotropium 18 µg capsule, bronchodilator
tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
Placebo
Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
2
placebo 18ug tiotropium for 1 month
Placebo
Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
Interventions
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Placebo
Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
Eligibility Criteria
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Inclusion Criteria
* Smoking history \> 10 pack yr.
* Clinically stable X 6 weeks.
* No oxygen usage.
Exclusion Criteria
* Clinically unstable
* Any other significant medical problem precluding full cooperation for study
40 Years
85 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Pfizer
INDUSTRY
Gelb, Arthur F., M.D.
INDIV
Responsible Party
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Principal Investigators
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Arthur F Gelb, MD
Role: PRINCIPAL_INVESTIGATOR
Arthur F Gelb Medical Corporation
Noe Zamel, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center
Locations
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Arthur F Gelb MD
Lakewood, California, United States
Noe Zamel MD
Toronto, Ontario, Canada
Countries
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References
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Gelb AF, Gutierrez CA, Weisman IM, Newsom R, Taylor CF, Zamel N. Simplified detection of dynamic hyperinflation. Chest. 2004 Dec;126(6):1855-60. doi: 10.1378/chest.126.6.1855.
Gelb AF, Taylor CF, McClean PA, Shinar CM, Rodrigues MT, Gutierrez CA, Chapman KR, Zamel N. Tiotropium and simplified detection of dynamic hyperinflation. Chest. 2007 Mar;131(3):690-695. doi: 10.1378/chest.06-1662.
Gelb AF, Fraser C, Zamel N. Lack of protective effect of tiotropium vs induced dynamic hyperinflation in moderate COPD. Respir Med. 2011 May;105(5):755-60. doi: 10.1016/j.rmed.2010.11.020. Epub 2010 Dec 14.
Other Identifiers
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IIS Boehringer-Ingelheim
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IIS Pfizer
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20061693
Identifier Type: -
Identifier Source: org_study_id
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