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Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

NCT ID: NCT00570544

Last Updated: 2008-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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COPD Emphysema

Keywords

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copd emphysema tiotropium lung function dynamic hyperinflation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

patients with moderate to severe copd with varying extent of emphysema

tiotropium

Intervention Type DRUG

18ug capsule daily for 30 days

Interventions

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tiotropium

18ug capsule daily for 30 days

Intervention Type DRUG

Other Intervention Names

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Spiriva

Eligibility Criteria

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Inclusion Criteria

* moderate to severe copd

Exclusion Criteria

* unable to tolerate tiotropium
* unable to perform metronome paced hyperventilation induced dynamic hyperinflation
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Gelb, Arthur F., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Arthur F Gelb Medical Corporation

Principal Investigators

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Arthur F Gelb, MD

Role: PRINCIPAL_INVESTIGATOR

Arthur F Gelb Medical Corporation

Locations

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Arthur F Gelb Medical Corporation

Lakewood, California, United States

Site Status

Countries

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United States

References

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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):690-695. doi: 10.1378/chest.06-1662.

Reference Type BACKGROUND
PMID: 17356081 (View on PubMed)

Gelb AF, Hogg JC, Muller 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. doi: 10.1378/chest.109.2.353.

Reference Type BACKGROUND
PMID: 8620705 (View on PubMed)

Other Identifiers

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Boehringer-Ingelheim Pharm.

Identifier Type: -

Identifier Source: secondary_id

Pfizer

Identifier Type: -

Identifier Source: secondary_id

1000

Identifier Type: -

Identifier Source: org_study_id