Clinical trial NCT02700919: Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: A Phase II, Two-Part, Randomised, Multi-Centre, Multinational, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Efficacy and Safety of BCT197 When Added on to Standard of Care for the Treatment of Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease Requiring Hospitalisation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 282
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline in FEV1 to Day 7 - ITT Population
timeFrame: Days 1 to 7
Secondary outcomes:
measure: Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population
timeFrame: Days 3, 10, and 14
measure: 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
timeFrame: Baseline, Days 1 to 7, Days 10 and 14, Week 8, Week 12 and Week 26
measure: 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
timeFrame: Baseline to Week 26
measure: Time to Improvement of 100 mL in FEV1 Over Time - ITT Population
timeFrame: Baseline to Week 26
measure: Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
timeFrame: Day 1 to Day 14
measure: Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
timeFrame: Day 1 to Day 14
measure: Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
timeFrame: Days 1 to 14
measure: 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
timeFrame: Days 1 to 29
measure: Time to Recovery Based on EXACT-PRO Total Score During the Acute Exacerbation Phase - ITT Population
timeFrame: Days 1 to 29
measure: Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
timeFrame: Days 1 to 29
measure: Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
timeFrame: Days 1 to 29
measure: Rate of Positively Adjudicated Moderate/Severe COPD Exacerbations - ITT Population
timeFrame: Day 1 to End of Study (Day 180)
measure: Number of COPD-Related Deaths During the Study - ITT Population
timeFrame: Days 1 to 180
measure: Time to Next Positively Adjudicated Moderate/Severe COPD Exacerbation- ITT Population
timeFrame: Day 1 to Day 180
measure: Time From Hospitalization Admission Until the Participant Is Medically Ready for Discharge (Current COPD) - ITT Population
timeFrame: Day 1 to Day 30
measure: Percentage of Days With Intake of COPD Rescue Therapy - ITT Population
timeFrame: Baseline to Week 26
Other outcomes:
measure: Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
timeFrame: Days 1 to 5
Locations:
city: Michigan City
country: United States
facility: Mereo Research Site
state: Indiana
city: Baltimore
country: United States
facility: Mereo Research Site
state: Maryland
city: Milwaukee
country: United States
facility: Mereo Research Site
state: Wisconsin
city: Dupnitsa
country: Bulgaria
facility: Mereo Research Site
city: Gabrovo
country: Bulgaria
facility: Mereo Research Site
city: Kardzhali
country: Bulgaria
facility: Mereo Research Site
city: Kozloduy
country: Bulgaria
facility: Mereo Research Site
city: Kyustendil
country: Bulgaria
facility: Mereo Research Site
city: Lovech
country: Bulgaria
facility: Mereo Research Site
city: Montana
country: Bulgaria
facility: Mereo Research Site
city: Razgrad
country: Bulgaria
facility: Mereo Research Site
city: Ruse
country: Bulgaria
facility: Mereo Research Site
city: Shumen
country: Bulgaria
facility: Mereo Research Site
city: Sliven
country: Bulgaria
facility: Mereo Research Site
city: Sofia
country: Bulgaria
facility: Mereo Research Site
city: Kyjov
country: Czechia
facility: Mereo Research Site
city: Melnik
country: Czechia
facility: Mereo Research Site
city: Slany
country: Czechia
facility: Mereo Research Site
city: Dresden
country: Germany
facility: Mereo Research Site
city: Balassagyarmat
country: Hungary
facility: Mereo Research Site
city: Budapest
country: Hungary
facility: Mereo Research Site
city: Debrecen
country: Hungary
facility: Mereo Research Site
city: Farkasgyepu
country: Hungary
facility: Mereo Research Site
city: Miskolc
country: Hungary
facility: Mereo Research Site
city: Mohacs
country: Hungary
facility: Mereo Research Site
city: Naples
country: Italy
facility: Mereo Research Site
city: Daugavpils
country: Latvia
facility: Mereo Research Site
city: Riga
country: Latvia
facility: Mereo Research Site
city: Valmiera
country: Latvia
facility: Mereo Research Site
city: Chrzanow
country: Poland
facility: Mereo Research Site
city: Krakow
country: Poland
facility: Mereo Research Site
city: Proszowice
country: Poland
facility: Mereo Research Site
city: Wroclaw
country: Poland
facility: Mereo Research Site
city: Zgierz
country: Poland
facility: Mereo Research Site
city: Bucharest
country: Romania
facility: Mereo Research Site
city: Cluj Napoca
country: Romania
facility: Mereo Research Site
city: Constanta
country: Romania
facility: Mereo Research Site
city: Craiova
country: Romania
facility: Mereo Research Site
city: Marghita
country: Romania
facility: Mereo Research Site
city: Suceava
country: Romania
facility: Mereo Research Site
city: Timisoara
country: Romania
facility: Mereo Research Site
city: Izhevsk
country: Russian Federation
facility: Mereo Research Site
city: Kemerovo
country: Russian Federation
facility: Mereo Research Site
city: Saint Petersburg
country: Russian Federation
facility: Mereo Research Site
city: Saratov
country: Russian Federation
facility: Mereo Research Site
city: Tomsk
country: Russian Federation
facility: Mereo Research Site
Study officials:
affiliation: Mereo BioPharma
name: Jacqueline Parkin, PhD FRCP
role: STUDY_DIRECTOR
References: