Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

NCT00570544

Last updated date
Study Location
Arthur F Gelb Medical Corporation
Lakewood, California, 90712, United States
Contact
1-800-718-1021

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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
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
  1. 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
  • COPD
  • Emphysema
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
 (submitted: December 10, 2007)
29
Original Actual Enrollment Same as current
Actual Study Completion Date August 2005
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria

  • moderate to severe copd

Exclusion Criteria

  • unable to tolerate tiotropium
  • unable to perform metronome paced hyperventilation induced dynamic hyperinflation
Sex/Gender
Sexes Eligible for Study:All
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
  • Boehringer Ingelheim
  • Pfizer
Investigators
Principal Investigator:Arthur F Gelb, MDArthur F Gelb Medical Corporation
PRS Account Gelb, Arthur F., M.D.
Verification Date December 2007