Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274027
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Mechanisms of Dyspnea Relief During Exercise in COPD Patients Following Treatment With Tiotropium Spiriva
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Randomised Double-Blind Placebo-Controlled Cross-Over Study to Examine the Effects of Tiotropium on Lung Hyperinflation Respiratory Mechanics and Dyspnea During Exercise in Patients With COPD
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore the mechanisms of dyspnea relief during exercise in patients with COPD following treatment with tiotropium bromide Spiriva
Detailed Description:
This was a single-centre randomised double-blind placebo-controlled cross-over study The duration of subject participation was 9 weeks There was an initial screening period of up to 2 weeks The first screening visit consisted of medical history clinical assessment chronic dyspnea evaluation complete pulmonary function testing and a symptom-limited maximal incremental cycle exercise test A second visit during the screening period was intended as a training of the subject to the procedures to be performed in the study with specific focus on familiarisation with the constant work rate exercise test The screening period was followed by 2 x 7 day treatment periods 1 x tiotropium and 1 x placebo separated by a 4 week washout period On the last day of each treatment period the subject visited the clinic to complete a series of trial related procedures including lung function measurements and a constant work rate exercise test at 75 Wcap to symptom limitation Testing consisted of pulmonary function testing dyspnea evaluation and symptom-limited constant-load cycle exercise tests with measurements of cardiopulmonary parameters symptom intensity and pulmonary mechanics
Study Hypothesis
Dynamic hyperinflation restricts volume expansion during exercise and is suspected as a primary mechanism of dyspnea The dissociation between drive or muscular effort to breathe and the mechanical response to increased volume as reflected by an increased PesPImax VTpredicted VC ratio correlates well with the intensity of inspiratory difficulty during exercise in COPD It was hypothesised that reduced Borg ratings at a standardized exercise level after tiotropium would correlate strongly with reduced restricted volume expansion during exercise ie increased VTIC and EILVTLC ratios and decreased IC and IRV In other words dyspnea and its predominant qualitative dimensions ie inspiratory difficulty result from patients being forced by DH to breathe at a high lung volume at or above predicted TLC
Comparisons
tiotropium bromide Spiriva vs placebo
Study Hypothesis
Dynamic hyperinflation restricts volume expansion during exercise and is suspected as a primary mechanism of dyspnea The dissociation between drive or muscular effort to breathe and the mechanical response to increased volume as reflected by an increased PesPImax VTpredicted VC ratio correlates well with the intensity of inspiratory difficulty during exercise in COPD It was hypothesised that reduced Borg ratings at a standardized exercise level after tiotropium would correlate strongly with reduced restricted volume expansion during exercise ie increased VTIC and EILVTLC ratios and decreased IC and IRV In other words dyspnea and its predominant qualitative dimensions ie inspiratory difficulty result from patients being forced by DH to breathe at a high lung volume at or above predicted TLC
Comparisons
tiotropium bromide Spiriva vs placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None