NCT00569270

Dynamic Hyperinflation and Tiotropium

Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Gelb, Arthur F., M.D. · Individual
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• COPD

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2007-12-07
• Last updated: 2019-08-20
• Results posted: 2012-10-05

Locations

2 sites across 2 countries: United States, Canada