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

NCT01958008 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-01-20

Study results available
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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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Placebo to BI 113608 high dose b.i.d.

Film-coated tablet

DRUG

Placebo to BI 113608 low dose b.i.d.

Film-coated tablet

DRUG

BI 113608 high dose b.i.d.

Film-coated tablet

DRUG

Placebo to BI 113608 medium dose b.i.d.

Film-coated tablet

DRUG

BI 113608 low dose b.i.d.

Film-coated tablet

DRUG

BI 113608 medium dose b.i.d.

Film-coated tablet

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958008 on ClinicalTrials.gov