NCT01818544

Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis

A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE). The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	BAY85-8501	BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
DRUG	Placebo	Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-03-26
• Last updated: 2015-07-09

Locations

33 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom