Phase 2
N=282
Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02700919 ↗Enrolled (actual)
282
Serious AEs
26.2%
Results posted
Nov 2020
Primary outcome: Primary: Change From Baseline in FEV1 to Day 7 - ITT Population — 0.084; 0.115; 0.057 litre — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BCT197 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Mereo BioPharma
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in FEV1 to Day 7 - ITT Population |
0.084; 0.115; 0.057 | 0.012 sig |
| SECONDARY Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population |
0.026; 0.059; 0.063; 0.095; 0.071; 0.063 | — |
| SECONDARY Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population |
67.9; 59.3; 64.6; 61.9; 65.2; 73.2 | — |
| SECONDARY Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population |
49.4; 47.8; 45.8; 51.8; 50.0; 55.4 | — |
| SECONDARY Time to Improvement of 100 mL in FEV1 Over Time - ITT Population |
3.0; 2.0; 4.0 | 0.399 |
| SECONDARY Area Under the Curve (AUC) of FEV1 Over Time - ITT Population |
1.207; 1.111; 1.097; 1.232; 1.143; 1.108 | — |
| SECONDARY Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population |
14.9; 20.4; 17.4; 28.7; 26.9; 26.7 | — |
| SECONDARY Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population |
-2.0; -1.0; -2.0; -3.0; -2.0; -2.0 | — |
| SECONDARY Time to Improvement Based on the EXAcerbations of Chronic Pulmonary Disease Tool-Patient Reported Outcome (EXACT-PRO) Total Score During the Acute Exacerbation Phase - ITT Population |
5.0; 6.0; 5.0 | 0.720 |
| SECONDARY Time to Recovery Based on EXACT-PRO Total Score During the Acute Exacerbation Phase - ITT Population |
6.0; 6.0; 6.0 | — |
| SECONDARY Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population |
45.389; 44.736; 43.938; 42.641; 42.250; 42.590 | — |
| SECONDARY Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population |
50.083; 47.861; 47.556; 45.417; 45.577; 44.436 | — |
| SECONDARY Rate of Positively Adjudicated Moderate/Severe COPD Exacerbations - ITT Population |
0.744; 0.921; 0.904 | — |
| SECONDARY Number of COPD-Related Deaths During the Study - ITT Population |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Time to Next Positively Adjudicated Moderate/Severe COPD Exacerbation- ITT Population |
168.0; 75.0; 143.0 | — |
| SECONDARY Time From Hospitalization Admission Until the Participant Is Medically Ready for Discharge (Current COPD) - ITT Population |
9.0; 9.0; 9.0 | — |
| SECONDARY Percentage of Days With Intake of COPD Rescue Therapy - ITT Population |
73.28; 71.90; 69.65; 70.78; 71.08; 67.35 | — |
Summary
The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.
Eligibility Criteria
Inclusion Criteria
- Male and female adults
- Presence of an active exacerbation of the ongoing COPD requiring hospitalization for treatment
- Subjects with a documented diagnosis of COPD C or D
- Current smokers or ex-smokers
- A documented history of at least one moderate or severe COPD exacerbation in the 12 months preceding the Screening Visit that required antibiotics and/or systemic corticosteroid.
- Current regular treatment for COPD (for at least 2 months prior to the Screening Visit.
Exclusion Criteria
- Age less than 40 years old
- Current diagnosis of asthma
- Subjects who have already completed treatment for the current exacerbation of COPD
- Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation
- Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined washout periods.
Data sourced from ClinicalTrials.gov (NCT02700919). 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.