At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 84 enrolled
Drug / intervention
Placebo to BI 113608 high dose b.i.d. +5 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.
Randomized, Placebo-controlled, Double-blind Within Dose Groups, Multiple Rising-dose Study to Evaluate Safety, Tolerability, and PK of Oral BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With COPD Associated With Chronic Bronchitis
In Brief
A Phase 1 clinical trial evaluating Placebo to BI 113608 high dose b.i.d., Placebo to BI 113608 low dose b.i.d., and 4 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 84 participants across 6 sites.
Detailed Summary
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedOct 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedOct 8, 2013
Enrollment StartSep 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.7 years ago
Interventions
Placebo to BI 113608 high dose b.i.d.drug
Film-coated tablet
Placebo to BI 113608 low dose b.i.d.drug
Film-coated tablet
BI 113608 high dose b.i.d.drug
Film-coated tablet
Placebo to BI 113608 medium dose b.i.d.drug
Film-coated tablet
BI 113608 low dose b.i.d.drug
Film-coated tablet
BI 113608 medium dose b.i.d.drug
Film-coated tablet