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| Sponsors and Collaborators: |
Gelb, Arthur F., M.D. Boehringer Ingelheim Pharmaceuticals Pfizer |
|---|---|
| Information provided by: | Gelb, Arthur F., M.D. |
| ClinicalTrials.gov Identifier: | NCT00569270 |
Purpose
We will detect dynamic hyperinflation (DH)in 40 COPD patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD |
Drug: tiotropium Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
tiotropium 18ug capsule for 1 month
|
Drug: tiotropium
tiotropium 18ug capsule daily for 1 month vs placebo
|
|
2: Placebo Comparator
placebo 18ug tiotropium for 1 month
|
Drug: placebo
18ug tiotropium placebo capsule daily for 1 month
|
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arthur F Gelb, MD | 562-633-2204 | afgelb@msn.com |
| Contact: Noe Zamel, MD | 416-586-4473 | noe@zamel.ca |
| United States, California | |
| Arthur F Gelb MD | Recruiting |
| Lakewood, California, United States, 90712 | |
| Contact: Arthur F Gelb, MD 562-633-2204 afgelb@msn.com | |
| Principal Investigator: Arthur F Gelb, MD | |
| Canada, Ontario | |
| Noe Zamel MD | Not yet recruiting |
| Toronto, Ontario, Canada | |
| Contact: Noe Zamel, MD noe@zamel.ca | |
| Principal Investigator: Noe Zamel, MD | |
| Principal Investigator: | Arthur F Gelb, MD | Arthur F Gelb Medical Corporation |
| Principal Investigator: | Noe Zamel, MD | Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center |
More Information
| Responsible Party: | Arthur F Gelb Medical Corporation ( Arthur F Gelb MD/Principal Investigator ) |
| Study ID Numbers: | 20061693, IIS Boehringer-Ingelheim, IIS Pfizer |
| Study First Received: | December 6, 2007 |
| Last Updated: | August 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00569270 |
| Health Authority: | United States: Institutional Review Board |
|
Tiotropium |
|
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Cholinergic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |
