Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema
NCT00570544
Last updated date
ABOUT THIS STUDY
To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in
patients with moderate to severe copd subjected to metronome paced hyperventilation induced
dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by
high resolution-thin section CT lung.
Study Location
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COPD, Emphysema
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
- moderate to severe copd
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- unable to tolerate tiotropium
- unable to perform metronome paced hyperventilation induced dynamic hyperinflation
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COPD, EmphysemaTiotropium Induced Bronchodilation in Lung CT Scored Emphysema
NCT00570544
- Lakewood, California
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema | |||
| Official Title | Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema | |||
| Brief Summary | To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in patients with moderate to severe copd subjected to metronome paced hyperventilation induced dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by high resolution-thin section CT lung. | |||
| Detailed Description | We will analyze post hoc, data that was previously published: Gelb AF et al.Chest 2006;131:690-695. We have shown that tiotropium increases resting inspiratory capacity thereby providing lung volume protection against metronome paced hyperventilation induced dynamic hyperinflation. End point will be to correlate increase in tiotropium induced FEV 1(L) and inspiratory capacity with extent of underlying emphysema as scored by lung CT ( Gelb AF et al:Chest 1996; 109: 353-359)in 29 patients with COPD. We will also correlate the decrease in inspiratory capacity following metronome paced hyperventilation induced dynamic hyperinflation with extent of lung CT scored emphysema. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Crossover Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | patients with moderate to severe copd from tertiary care pulmonary clinic | |||
| Condition |
| |||
| Intervention | Drug: tiotropium
18ug capsule daily for 30 days Other Name: Spiriva | |||
| Study Groups/Cohorts | 1
patients with moderate to severe copd with varying extent of emphysema Intervention: Drug: tiotropium | |||
| Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 29 | |||
| Original Actual Enrollment | Same as current | |||
| Actual Study Completion Date | August 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria | Inclusion Criteria
Exclusion Criteria
| |||
| Sex/Gender |
| |||
| Ages | 40 Years to 85 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00570544 | |||
| Other Study ID Numbers | 1000 Boehringer-Ingelheim Pharm. Pfizer | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Arthur F Gelb MD, Arthur F Gelb Medical Corporation | |||
| Study Sponsor | Gelb, Arthur F., M.D. | |||
| Collaborators |
| |||
| Investigators |
| |||
| PRS Account | Gelb, Arthur F., M.D. | |||
| Verification Date | December 2007 | |||