Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

Overview

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.

Full Title of Study: “Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective

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.

Interventions

  • Drug: tiotropium
    • 18ug capsule daily for 30 days

Arms, Groups and Cohorts

  • 1
    • patients with moderate to severe copd with varying extent of emphysema

Clinical Trial Outcome Measures

Primary Measures

  • Correlate tiotropium induced increase in inspiratory capacity (IC)and FEV 1 with extent of emphysema as scored by lung CT.
    • Time Frame: After 30 days and 1.5hr of tiotropium

Secondary Measures

  • Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema.
    • Time Frame: After 30 days and 1.5hr of tiotropium

Participating in This Clinical Trial

Inclusion Criteria

  • moderate to severe copd

Exclusion Criteria

  • unable to tolerate tiotropium
  • unable to perform metronome paced hyperventilation induced dynamic hyperinflation

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gelb, Arthur F., M.D.
  • Collaborator
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Arthur F Gelb MD, Arthur F Gelb Medical Corporation
  • Overall Official(s)
    • Arthur F Gelb, MD, Principal Investigator, Arthur F Gelb Medical Corporation

References

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.

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.

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