At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 183 enrolled
Drug / intervention
BCT197 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation
In Brief
A Phase 2 clinical trial evaluating BCT197, Prednisone placebo, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 183 participants across 6 sites in 3 countries.
Detailed Summary
This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBulgaria, Romania, Russia
CollaboratorsNovartis
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedApr 2011
Primary CompletionMay 2013
TodayJul 2026
First PostedApr 8, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.2 years ago
Interventions
BCT197drug
Prednisone placebodrug
capsules
BCT197 placebodrug
capsules
Prednisonedrug
capsules