Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease
NCT ID: NCT02700919
Last Updated: 2020-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2016-08-01
2017-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Regimen 1
Drug: BCT197 Dose 1, Day 1 to Day 5
BCT197
Capsules will be taken orally with fluids over a 5 day period after randomization
Regimen 2
Drug: BCT197 Dose 2, Day 1 to Day 5
BCT197
Capsules will be taken orally with fluids over a 5 day period after randomization
Regimen 3
Placebo Day 1 to Day 5
Placebo
Capsules will be taken orally with fluids over a 5 day period after randomization
Interventions
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BCT197
Capsules will be taken orally with fluids over a 5 day period after randomization
Placebo
Capsules will be taken orally with fluids over a 5 day period after randomization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Mereo BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Jacqueline Parkin, PhD FRCP
Role: STUDY_DIRECTOR
Mereo BioPharma
Locations
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Mereo Research Site
Michigan City, Indiana, United States
Mereo Research Site
Baltimore, Maryland, United States
Mereo Research Site
Milwaukee, Wisconsin, United States
Mereo Research Site
Dupnitsa, , Bulgaria
Mereo Research Site
Gabrovo, , Bulgaria
Mereo Research Site
Kardzhali, , Bulgaria
Mereo Research Site
Kozloduy, , Bulgaria
Mereo Research Site
Kyustendil, , Bulgaria
Mereo Research Site
Lovech, , Bulgaria
Mereo Research Site
Montana, , Bulgaria
Mereo Research Site
Razgrad, , Bulgaria
Mereo Research Site
Rousse, , Bulgaria
Mereo Research Site
Shumen, , Bulgaria
Mereo Research Site
Sliven, , Bulgaria
Mereo Research Site
Sofia, , Bulgaria
Mereo Research Site
Kyjov, , Czechia
Mereo Research Site
Mělník, , Czechia
Mereo Research Site
Slaný, , Czechia
Mereo Research Site
Dresden, , Germany
Mereo Research Site
Balassagyarmat, , Hungary
Mereo Research Site
Budapest, , Hungary
Mereo Research Site
Debrecen, , Hungary
Mereo Research Site
Farkasgyepű, , Hungary
Mereo Research Site
Miskolc, , Hungary
Mereo Research Site
Mohács, , Hungary
Mereo Research Site
Naples, , Italy
Mereo Research Site
Daugavpils, , Latvia
Mereo Research Site
Riga, , Latvia
Mereo Research Site
Valmiera, , Latvia
Mereo Research Site
Chrzanów, , Poland
Mereo Research Site
Krakow, , Poland
Mereo Research Site
Proszowice, , Poland
Mereo Research Site
Wroclaw, , Poland
Mereo Research Site
Zgierz, , Poland
Mereo Research Site
Bucharest, , Romania
Mereo Research Site
Cluj-Napoca, , Romania
Mereo Research Site
Constanța, , Romania
Mereo Research Site
Craiova, , Romania
Mereo Research Site
Marghita, , Romania
Mereo Research Site
Suceava, , Romania
Mereo Research Site
Timișoara, , Romania
Mereo Research Site
Izhevsk, , Russia
Mereo Research Site
Kemerovo, , Russia
Mereo Research Site
Saint Petersburg, , Russia
Mereo Research Site
Saratov, , Russia
Mereo Research Site
Tomsk, , Russia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MBCT206
Identifier Type: -
Identifier Source: org_study_id