A Phase 2 interventional study of BEA 2180 BR and tiotropium in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 43 sites in 3 countries. Open to participants aged 40 Years to 83 Years. Per ClinicalTrials.gov, last updated 2017-12-28.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 389 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.
Trough forced expiratory volume (FEV1) response after four weeks of treatment.
Time frame: 4 weeks
Trough FEV1 response after 1 and 2 weeks
Time frame: after 1 and 2 weeks
Trough FVC response after 1, 2 and 4 weeks
Time frame: after 1, 2 and 4 weeks
FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks
Time frame: after 0, 1, 2 and 4 weeks
Individual FEV1 and FVC measurements at each time point
Time frame: 4 weeks
Weekly mean pre-dose morning and evening PEFR
Time frame: 4 weeks
Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
Time frame: 4 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: 4 weeks
Physician's Global Evaluation
Time frame: 4 weeks
All adverse events
Time frame: 7 weeks
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)
Time frame: 4 weeks
12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)
Time frame: 4 weeks
drug plasma concentrations
Time frame: 4 or 7 weeks
drug urine concentrations
Time frame: 4 or 7 weeks
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim