Dynamic Hyperinflation and Tiotropium

NCT00569270

Last updated date
Study Location
Arthur F Gelb MD
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
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

- 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
  • Active Comparator: 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
    Intervention: Drug: Placebo
  • Placebo Comparator: 2
    placebo 18ug tiotropium for 1 month
    Intervention: Drug: Placebo
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2007)
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:

  • 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:

  • History of asthma
  • Clinically unstable
  • Any other significant medical problem precluding full cooperation for study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:No
Plan Description:Please see published data
Responsible Party Gelb, Arthur F., M.D.
Study Sponsor  ICMJE Gelb, Arthur F., M.D.
Collaborators  ICMJE
  • Boehringer Ingelheim
  • Pfizer
Investigators  ICMJE
Principal Investigator:Arthur F Gelb, MDArthur F Gelb Medical Corporation
Principal Investigator:Noe Zamel, MDMt. Sinai Hosp. Toronto, Univ Toronto Medical Center
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