A Phase 3 interventional study of Tiotropium Bromide and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 27 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-11-01.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18 mcg once daily by oral inhalation compared to placebo increases the magnitude of daily physical activity observed in COPD patients, measured using an accelerometer.
This is a 3 month, multicentre, randomised, double-blind, placebo controlled, parallel group study to compare with placebo the long-term effect of tiotropium inhalation capsules on daily physical activity in patients with COPD.
The drugs will be administered in the form of inhalation capsules of tiotropium or placebo, taken once daily in the morning.
The record of daily physical activity using the accelerometer will be carried out at all study visits other than Visit 1. The accelerometer will be used for the five day period, from Thursday to Monday, closest to the corresponding visit.
The pulmonary function tests will be carried out at Visit 1 (screening visit), Visit 2 (baseline visit) and study visits (Visits 3 to 5) with the restrictions detailed at the trial protocol.
Study Hypothesis:
The null hypothesis is that there is no difference between tiotropium (Spiriva) and placebo regarding the magnitude of exercise measured with an accelerometer. The alternative hypothesis is that there is a difference between tiotropium (Spiriva) and placebo regarding the magnitude of exercise measured with an accelerometer.
Comparison(s):
The difference in physical activity measured in vector magnitude units (VMUs) by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 250 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of COPD and meets the following spirometric criteria:
Exclusion Criteria:
Primary endpoint: The primary efficacy variable will be the difference in physical activity measured in vector magnitude units (VMUs) by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo.
Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim