A Phase 2 interventional study of Tiotropium and Salmeterol in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 12 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-05-30.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 103 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive 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:
Drug: Tiotropium · Drug: Salmeterol · Drug: Fluticasone
Drug: Tiotropium · Drug: Salmeterol · Drug: Ciclesonide low
Drug: Tiotropium · Drug: Salmeterol · Drug: Ciclesonide high
Drug: Tiotropium · Drug: Salmeterol · Drug: Placebo
Oral inhalation by HandiHaler® device
Oral inhalation from Diskus®
Oral inhalation from metered dose inhaler (MDI)
Oral inhalation from MDI
Oral inhalation from MDI
Oral inhalation from MDI
Trough FEV1 response at the end of each 4 week period of randomised treatment
Time frame: 4 weeks
Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
All adverse events
Time frame: 24 weeks
Pulse rate and blood pressure (seated)
Time frame: 24 weeks
FEV1 and FVC morning peak response
Time frame: day 1 and day 28 of each blinded treatment
FEV1 and FVC evening peak response
Time frame: day 1 and day 28 of each blinded treatment
FEV1 AUC (0-3h), after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
FEV1 AUC (12-15h) after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
FVC AUC (0-3h) after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
FVC AUC (12-15h) after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period
Time frame: day 1 and day 28 of each blinded treatment
Weekly mean pre-dose morning and evening peak expiratory flow (PEF)
Time frame: 28 weeks
Weekly mean number of occasions of rescue therapy used per day
Time frame: 28 weeks
Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period
Time frame: 28 weeks
Fractional exhaled nitric oxide after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Boehringer Ingelheim