A Phase 3 interventional study of Tiotropium and Respimat SMI in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 2 sites in 2 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
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 76 is close to 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.
Exclusion Criteria:
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
Time frame: baseline until week 28
Peak response (FEV1 and FVC) to first dose
Time frame: within 3 hours to first dose
Peak response (FEV1 and FVC) after 4 weeks
Time frame: within 3 hours after 4 weeks
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
Time frame: after 4 weeks
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
Time frame: after first dose and after 4 weeks
Individual FEV1and FVC measurements at each time point
Time frame: up to 28 weeks
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
Time frame: up to 28 weeks
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
Time frame: up to 28 weeks
Median time to onset of therapeutic response after first dose
Time frame: after 4 weeks
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
Time frame: at week 4, 12, 20
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
Time frame: at week 8, 16, 24
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