BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo to BI 113608 medium dose b.i.d.; Drug: Placebo to BI 113608 high dose b.i.d.; Drug: Placebo to BI 113608 low dose b.i.d.; Drug: BI 113608 medium dose b.i.d.; Drug: BI 113608 high dose b.i.d.; Drug: BI 113608 low dose b.i.d.

• Registration Number: NCT01958008
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-11
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Results First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 113608 medium dose b.i.d.	Placebo to BI 113608 medium dose b.i.d.	Film-coated tablet, oral administration with 240 mL water
BI 113608 medium dose b.i.d.	BI 113608 medium dose b.i.d.	Film-coated tablet, oral administration with 240 mL water
BI 113608 high dose b.i.d.	Placebo to BI 113608 high dose b.i.d.	Film-coated tablet, oral administration with 240 mL water
BI 113608 high dose b.i.d.	BI 113608 high dose b.i.d.	Film-coated tablet, oral administration with 240 mL water
BI 113608 low dose b.i.d.	Placebo to BI 113608 low dose b.i.d.	Film-coated tablet, oral administration with 240 mL water
BI 113608 low dose b.i.d.	BI 113608 low dose b.i.d.	Film-coated tablet, oral administration with 240 mL water

Primary Outcome Measures

Name	Time	Method
Number (%) of Patients With Drug-related Adverse Events (AEs)	AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)	Number (%) of patients with drug-related adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Cmax,ss	Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration	Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)
Tmax,ss	Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration	Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)
T1/2,ss	Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration	T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)
R(A,AUC)	Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration	R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)
R(A,Cmax)	Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration	R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)
AUC Tau,ss	Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration	AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany