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ABOUT THIS STUDY
We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease)
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Pfizer Clinical Trials Contact Center
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COPD
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
40-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC < 70%.
- Smoking history > 10 pack yr.
- Clinically stable X 6 weeks.
- No oxygen usage.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- History of asthma
- Clinically unstable
- Any other significant medical problem precluding full cooperation for study
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Dynamic Hyperinflation and Tiotropium | ||||||
| Official Title ICMJE | Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD | ||||||
| Brief Summary | We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) 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. | ||||||
| Detailed Description | Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE | COPD | ||||||
| Intervention ICMJE | Drug: 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 | ||||||
| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 30 | ||||||
| Original Estimated Enrollment ICMJE | 40 | ||||||
| Actual Study Completion Date ICMJE | March 2009 | ||||||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 85 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Canada, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00569270 | ||||||
| Other Study ID Numbers ICMJE | 20061693 IIS Boehringer-Ingelheim ( Other Grant/Funding Number: Boehringer-Ingelheim and Pfizer ) IIS Pfizer ( Other Grant/Funding Number: Pfizer ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Gelb, Arthur F., M.D. | ||||||
| Study Sponsor ICMJE | Gelb, Arthur F., M.D. | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Gelb, Arthur F., M.D. | ||||||
| Verification Date | July 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||