Phase 2 N=183 Randomized Double-blind Treatment

Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT01332097 ↗

Enrolled (actual)

183

Serious AEs

10.4%

Results posted

Mar 2023

Primary outcome: Primary: Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second — 155.1; 100.8; 48.9; 106.3 mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BCT197 (Drug); Prednisone placebo (Drug); BCT197 placebo (Drug); Prednisone (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Mereo BioPharma
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second	155.1; 100.8; 48.9; 106.3; 134.4; 200.6	—
SECONDARY Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO	5.72; 8.89; 5.19; 5.83; 7.89; 8.35	—

Summary

This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

Eligibility Criteria

Inclusion Criteria

Patients with COPD (Stage II to IV) with a COPD exacerbation.
Smoking history of 10 pack years.
Females must not be of child-bearing potential.

Exclusion Criteria

Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01332097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.