A Phase 3 interventional study of 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler and 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 38 sites in 4 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 primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 429 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.
Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted [ECCS criteria] and FEV1/FVC \</= 70%)
Trough FEV1 response
Time frame: after 12 weeks
Trough FEV1 response
Time frame: after 1, 4 and 8 weeks
Trough FVC response
Time frame: after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve (AUC)0-6h and peak response
Time frame: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements
Time frame: during 12 weeks
Onset and duration of therapeutic response and percentage of responders
Time frame: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Time frame: up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Time frame: up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: up to 15 weeks
Physician's Global Evaluation
Time frame: up to 15 weeks
Number of patients with at least one exacerbation of COPD
Time frame: up to 15 weeks
Time to first exacerbation
Time frame: up to 15 weeks
Number of exacerbations and exacerbation days
Time frame: up to 15 weeks
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