NCT01818544

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

Completed Phase 2 Last updated 8 July 2015

What this trial tests

Phase 2 trial testing BAY85-8501 in Bronchiectasis in 94 participants. Completed in 1 June 2014.

Timeline

1 April 2013

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	94
Start date	1 April 2013
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	33 locations across France, Germany, Italy, Spain, United Kingdom

Drugs / interventions tested

• BAY85-8501 — full drug profile →
• Placebo

Conditions studied

• Bronchiectasis — all drugs for Bronchiectasis →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Bronchiectasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination
  Time frame: From start of study treatment up to follow up visit (28 days after last dose)
• Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56
  Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
• Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56
  Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
• Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56
  Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
• Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28
  Time frame: Baseline (Day 1), Day 7, 14, 21, 28
• Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment
  Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Neutrophils to Treat Acute Respiratory Distress Syndrome in Coronavirus Disease.
   Chiang CC, Korinek M, Cheng WJ, Hwang TL. · · 2020 · cited 97× · PMID 33162887 · DOI 10.3389/fphar.2020.572009
2. Neutrophils as emerging protagonists and targets in chronic inflammatory diseases.
   Rawat K, Shrivastava A. · · 2022 · cited 35× · PMID 36289077 · DOI 10.1007/s00011-022-01627-6
3. A systematic review of pharmacotherapeutic clinical trial end-points for bronchiectasis in adults.
   Crichton ML, Aliberti S, Chalmers JD. · · 2019 · cited 28× · PMID 30872400 · DOI 10.1183/16000617.0108-2018
4. Targets of Neutrophil Influx and Weaponry: Therapeutic Opportunities for Chronic Obstructive Airway Disease.
   Mårdh CK, Root J, Uddin M, Stenvall K, et al · · 2017 · cited 22× · PMID 28596972 · DOI 10.1155/2017/5273201