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NCT00570544 Clinical Trial

Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

COPD Clinical Trial

Official title:
Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00570544
Other study ID # 1000
Secondary ID Boehringer-Ingel
Status Completed
Phase Phase 4
First received December 10, 2007
Last updated August 13, 2008
Start date August 2004
Est. completion date August 2005

Study information
Verified date December 2007
Source Gelb, Arthur F., M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria

- moderate to severe copd

Exclusion Criteria

- unable to tolerate tiotropium

- unable to perform metronome paced hyperventilation induced dynamic hyperinflation

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• tiotropium
18ug capsule daily for 30 days

Locations
Country Name City State
United States Arthur F Gelb Medical Corporation Lakewood California

Sponsors (3)
Lead Sponsor Collaborator
Gelb, Arthur F., M.D. Boehringer Ingelheim, Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gelb AF, Hogg JC, Müller NL, Schein MJ, Kuei J, Tashkin DP, Epstein JD, Kollin J, Green RH, Zamel N, Elliott WM, Hadjiaghai L. Contribution of emphysema and small airways in COPD. Chest. 1996 Feb;109(2):353-9. — View Citation

Gelb AF, Taylor CF, McClean PA, Shinar CM, Rodrigues MT, Gutierrez CA, Chapman KR, Zamel N. Tiotropium and simplified detection of dynamic hyperinflation. Chest. 2007 Mar;131(3):690-5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Correlate tiotropium induced increase in inspiratory capacity (IC)and FEV 1 with extent of emphysema as scored by lung CT. After 30 days and 1.5hr of tiotropium No
Secondary Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema. After 30 days and 1.5hr of tiotropium No
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