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Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BCT197
Placebo
Sponsored by
Mereo BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site
  • Mereo Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Regimen 1

Regimen 2

Regimen 3

Arm Description

Drug: BCT197 Dose 1, Day 1 to Day 5

Drug: BCT197 Dose 2, Day 1 to Day 5

Placebo Day 1 to Day 5

Outcomes

Primary Outcome Measures

Change From Baseline in FEV1 to Day 7 - ITT Population
FEV1 data were recorded daily from Days 1 to 7 of the study using a computer-operated spirometer. Analysis was based on a linear Mixed Model for Repeated Measures (MMRM) with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current chronic obstructive pulmonary disease (COPD) exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Results were presented with adjusted mean (95% confidence interval).

Secondary Outcome Measures

Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population
FEV1 data were recorded daily from Days 1 to 7, and Days 10 and 14 of the study using a computer-operated spirometer. Analysis was based on a linear MMRM with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current COPD exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
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
FEV1 data were recorded daily from Days 1 to 7 and on Days 10 and 14 and Weeks 8, 12, and 26 of the study using a computer-operated spirometer. FEV1 normalization was achieved if FEV1 returned to a value ≥ 89% of the most recent FEV1 value measured within the last 12 months outside an exacerbation (pre-study FEV1 value). Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Percentages (%) were based on number of non-missing values as denominator.
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
FEV1 and FVC were recorded daily from Days 1 to 7 and on Days 10 and 14 and Weeks 8, 12, and 26 of the study using a computer-operated spirometer. FEV1/FVC normalization was achieved if FEV1/FVC returned to a value ≥ 89% of the most recent FEV1/FVC value measured within the last 12 months outside an exacerbation (pre-study FEV1/FVC value). Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Time to Improvement of 100 mL in FEV1 Over Time - ITT Population
Time to improvement of 100 mL in FEV1 was defined as time (in days) from initiation of study treatment until the change in FEV1 was ≥ +100 mL.
Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
AUC was calculated according to the trapezoidal rule. The trapezoidal rule is a numerical method to be used to approximate the integral or the area under a curve. Using trapezoidal rule to approximate the area under a curve first involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when the upper end is replaced by a chord. The sum of these approximations gives the final numerical result of the AUC.
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
RR was normalized when it returned to a baseline plateau level achieved after the acute COPD exacerbation during the Stabilization Phase. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
RR (breaths/min) was recorded over time during the acute exacerbation phase.
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
Improvement based on EXACT-PRO total score is defined as a decrease in the Rolling Average EXACT score ≥ 9 points from the previous day's maximum observed value during an event. The EXACT is a 14-item patient reported outcome (PRO) daily diary used to quantify and measure exacerbations of COPD. The health status of the participant is correlated to the global score, meaning a higher score corresponds to a more severe health status of the participant. An EXACT Total score is computed for each day of diary collection. The EXACT Total score is based on a logit scoring system with conversion to a 0 to 100 scale for ease of interpretation and use. The total score was used in the determination of exacerbation frequency, severity and duration of exacerbation. Specifically, changes in the total score were used to define onset and recovery from an exacerbation event and the magnitude of that event.
Time to Recovery Based on EXACT-PRO Total Score During the Acute Exacerbation Phase - ITT Population
Recovery based on EXACT-PRO total score was defined as the first day in which a participant experiences a persistent, sustained improvement in their condition over the observed period (Day 1 to Day 29). Improvement had to be present for 7 consecutive days. The first day of the 7-day period was designated as the first day of Recovery. An EXACT total score was computed for each day of diary collection.
Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
The standardized AUC of the EXACT-PRO were calculated from Day (a) to Day (b) using the trapezoidal rule.
Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Information regarding the participant's condition can be obtained through 3 domain scores embedded within the EXACT measure: Breathlessness, Cough & Sputum, and Chest Symptoms. These scores also range from 0 to 100 with higher scores indicating more severe symptoms.The standardized AUC of the EXACT-PRO were calculated from Day (a) to Day (b) using the trapezoidal rule.
Rate of Positively Adjudicated Moderate/Severe COPD Exacerbations - ITT Population
Follow-up time per participant (years) was defined as (date of last contact - date of first study drug administration + 1)/ 365.25. Total follow-up time (years) = sum of individual participant follow-up times. Rate was calculated as total number of positively adjudicated exacerbations divided by the total follow-up time in years of the treatment group.
Number of COPD-Related Deaths During the Study - ITT Population
Cumulative incidences of COPD-related deaths until Day 30/60/90/120/150/180 were obtained.
Time to Next Positively Adjudicated Moderate/Severe COPD Exacerbation- ITT Population
Time to next positively adjudicated moderate/severe COPD exacerbation (in days) was defined as date when first moderate/severe COPD exacerbation symptoms started - date when current COPD exacerbation symptoms stopped, where COPD exacerbations experienced during the study were positively adjudicated by the Independent Adjudication Committee. Time to next positively adjudicated COPD exacerbation was presented in 25th percentile (95% confidence interval) as medians were not evaluable.
Time From Hospitalization Admission Until the Participant Is Medically Ready for Discharge (Current COPD) - ITT Population
Time from hospitalization admission until the participant is medically ready for discharge (in days) = Date participant was medically ready for discharge from hospital - Date of hospitalization admission. Date of hospitalization admission' and 'Date participant was medically ready for discharge from hospital' were recorded on the 'Current COPD Exacerbation' form of the eCRF. Results were presented with 75th percentile (95% CI) due to the fact that 95% CI for the median was not evaluable.
Percentage of Days With Intake of COPD Rescue Therapy - ITT Population
Participants completed the EXACT-PRO starting from Day 1 and recorded rescue medication use and any occurrences of COPD once a day (evening) in the diary. The percentage of days with intake of rescue medications was evaluated on the basis of the information recorded daily by the participant on the diaries. A day was considered with intake of rescue medications if the answer to the question "How many puffs of rescue medication did you take since last evening?" was> 0.

Full Information

First Posted
February 29, 2016
Last Updated
November 4, 2020
Sponsor
Mereo BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT02700919
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mereo BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1
Arm Type
Experimental
Arm Description
Drug: BCT197 Dose 1, Day 1 to Day 5
Arm Title
Regimen 2
Arm Type
Experimental
Arm Description
Drug: BCT197 Dose 2, Day 1 to Day 5
Arm Title
Regimen 3
Arm Type
Placebo Comparator
Arm Description
Placebo Day 1 to Day 5
Intervention Type
Drug
Intervention Name(s)
BCT197
Intervention Description
Capsules will be taken orally with fluids over a 5 day period after randomization
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules will be taken orally with fluids over a 5 day period after randomization
Primary Outcome Measure Information:
Title
Change From Baseline in FEV1 to Day 7 - ITT Population
Description
FEV1 data were recorded daily from Days 1 to 7 of the study using a computer-operated spirometer. Analysis was based on a linear Mixed Model for Repeated Measures (MMRM) with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current chronic obstructive pulmonary disease (COPD) exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Results were presented with adjusted mean (95% confidence interval).
Time Frame
Days 1 to 7
Secondary Outcome Measure Information:
Title
Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population
Description
FEV1 data were recorded daily from Days 1 to 7, and Days 10 and 14 of the study using a computer-operated spirometer. Analysis was based on a linear MMRM with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current COPD exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Time Frame
Days 3, 10, and 14
Title
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
Description
FEV1 data were recorded daily from Days 1 to 7 and on Days 10 and 14 and Weeks 8, 12, and 26 of the study using a computer-operated spirometer. FEV1 normalization was achieved if FEV1 returned to a value ≥ 89% of the most recent FEV1 value measured within the last 12 months outside an exacerbation (pre-study FEV1 value). Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Percentages (%) were based on number of non-missing values as denominator.
Time Frame
Baseline, Days 1 to 7, Days 10 and 14, Week 8, Week 12 and Week 26
Title
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
Description
FEV1 and FVC were recorded daily from Days 1 to 7 and on Days 10 and 14 and Weeks 8, 12, and 26 of the study using a computer-operated spirometer. FEV1/FVC normalization was achieved if FEV1/FVC returned to a value ≥ 89% of the most recent FEV1/FVC value measured within the last 12 months outside an exacerbation (pre-study FEV1/FVC value). Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Time Frame
Baseline to Week 26
Title
Time to Improvement of 100 mL in FEV1 Over Time - ITT Population
Description
Time to improvement of 100 mL in FEV1 was defined as time (in days) from initiation of study treatment until the change in FEV1 was ≥ +100 mL.
Time Frame
Baseline to Week 26
Title
Area Under the Curve (AUC) of FEV1 Over Time - ITT Population
Description
AUC was calculated according to the trapezoidal rule. The trapezoidal rule is a numerical method to be used to approximate the integral or the area under a curve. Using trapezoidal rule to approximate the area under a curve first involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when the upper end is replaced by a chord. The sum of these approximations gives the final numerical result of the AUC.
Time Frame
Day 1 to Day 14
Title
Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population
Description
RR was normalized when it returned to a baseline plateau level achieved after the acute COPD exacerbation during the Stabilization Phase. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.
Time Frame
Day 1 to Day 14
Title
Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population
Description
RR (breaths/min) was recorded over time during the acute exacerbation phase.
Time Frame
Days 1 to 14
Title
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
Description
Improvement based on EXACT-PRO total score is defined as a decrease in the Rolling Average EXACT score ≥ 9 points from the previous day's maximum observed value during an event. The EXACT is a 14-item patient reported outcome (PRO) daily diary used to quantify and measure exacerbations of COPD. The health status of the participant is correlated to the global score, meaning a higher score corresponds to a more severe health status of the participant. An EXACT Total score is computed for each day of diary collection. The EXACT Total score is based on a logit scoring system with conversion to a 0 to 100 scale for ease of interpretation and use. The total score was used in the determination of exacerbation frequency, severity and duration of exacerbation. Specifically, changes in the total score were used to define onset and recovery from an exacerbation event and the magnitude of that event.
Time Frame
Days 1 to 29
Title
Time to Recovery Based on EXACT-PRO Total Score During the Acute Exacerbation Phase - ITT Population
Description
Recovery based on EXACT-PRO total score was defined as the first day in which a participant experiences a persistent, sustained improvement in their condition over the observed period (Day 1 to Day 29). Improvement had to be present for 7 consecutive days. The first day of the 7-day period was designated as the first day of Recovery. An EXACT total score was computed for each day of diary collection.
Time Frame
Days 1 to 29
Title
Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Description
The standardized AUC of the EXACT-PRO were calculated from Day (a) to Day (b) using the trapezoidal rule.
Time Frame
Days 1 to 29
Title
Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population
Description
Information regarding the participant's condition can be obtained through 3 domain scores embedded within the EXACT measure: Breathlessness, Cough & Sputum, and Chest Symptoms. These scores also range from 0 to 100 with higher scores indicating more severe symptoms.The standardized AUC of the EXACT-PRO were calculated from Day (a) to Day (b) using the trapezoidal rule.
Time Frame
Days 1 to 29
Title
Rate of Positively Adjudicated Moderate/Severe COPD Exacerbations - ITT Population
Description
Follow-up time per participant (years) was defined as (date of last contact - date of first study drug administration + 1)/ 365.25. Total follow-up time (years) = sum of individual participant follow-up times. Rate was calculated as total number of positively adjudicated exacerbations divided by the total follow-up time in years of the treatment group.
Time Frame
Day 1 to End of Study (Day 180)
Title
Number of COPD-Related Deaths During the Study - ITT Population
Description
Cumulative incidences of COPD-related deaths until Day 30/60/90/120/150/180 were obtained.
Time Frame
Days 1 to 180
Title
Time to Next Positively Adjudicated Moderate/Severe COPD Exacerbation- ITT Population
Description
Time to next positively adjudicated moderate/severe COPD exacerbation (in days) was defined as date when first moderate/severe COPD exacerbation symptoms started - date when current COPD exacerbation symptoms stopped, where COPD exacerbations experienced during the study were positively adjudicated by the Independent Adjudication Committee. Time to next positively adjudicated COPD exacerbation was presented in 25th percentile (95% confidence interval) as medians were not evaluable.
Time Frame
Day 1 to Day 180
Title
Time From Hospitalization Admission Until the Participant Is Medically Ready for Discharge (Current COPD) - ITT Population
Description
Time from hospitalization admission until the participant is medically ready for discharge (in days) = Date participant was medically ready for discharge from hospital - Date of hospitalization admission. Date of hospitalization admission' and 'Date participant was medically ready for discharge from hospital' were recorded on the 'Current COPD Exacerbation' form of the eCRF. Results were presented with 75th percentile (95% CI) due to the fact that 95% CI for the median was not evaluable.
Time Frame
Day 1 to Day 30
Title
Percentage of Days With Intake of COPD Rescue Therapy - ITT Population
Description
Participants completed the EXACT-PRO starting from Day 1 and recorded rescue medication use and any occurrences of COPD once a day (evening) in the diary. The percentage of days with intake of rescue medications was evaluated on the basis of the information recorded daily by the participant on the diaries. A day was considered with intake of rescue medications if the answer to the question "How many puffs of rescue medication did you take since last evening?" was> 0.
Time Frame
Baseline to Week 26
Other Pre-specified Outcome Measures:
Title
Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population
Description
Descriptive summary of PK plasma concentration is presented as no-specific PK report is available.
Time Frame
Days 1 to 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Parkin, PhD FRCP
Organizational Affiliation
Mereo BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Mereo Research Site
City
Michigan City
State/Province
Indiana
Country
United States
Facility Name
Mereo Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Mereo Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Mereo Research Site
City
Dupnitsa
Country
Bulgaria
Facility Name
Mereo Research Site
City
Gabrovo
Country
Bulgaria
Facility Name
Mereo Research Site
City
Kardzhali
Country
Bulgaria
Facility Name
Mereo Research Site
City
Kozloduy
Country
Bulgaria
Facility Name
Mereo Research Site
City
Kyustendil
Country
Bulgaria
Facility Name
Mereo Research Site
City
Lovech
Country
Bulgaria
Facility Name
Mereo Research Site
City
Montana
Country
Bulgaria
Facility Name
Mereo Research Site
City
Razgrad
Country
Bulgaria
Facility Name
Mereo Research Site
City
Ruse
Country
Bulgaria
Facility Name
Mereo Research Site
City
Shumen
Country
Bulgaria
Facility Name
Mereo Research Site
City
Sliven
Country
Bulgaria
Facility Name
Mereo Research Site
City
Sofia
Country
Bulgaria
Facility Name
Mereo Research Site
City
Kyjov
Country
Czechia
Facility Name
Mereo Research Site
City
Melnik
Country
Czechia
Facility Name
Mereo Research Site
City
Slany
Country
Czechia
Facility Name
Mereo Research Site
City
Dresden
Country
Germany
Facility Name
Mereo Research Site
City
Balassagyarmat
Country
Hungary
Facility Name
Mereo Research Site
City
Budapest
Country
Hungary
Facility Name
Mereo Research Site
City
Debrecen
Country
Hungary
Facility Name
Mereo Research Site
City
Farkasgyepu
Country
Hungary
Facility Name
Mereo Research Site
City
Miskolc
Country
Hungary
Facility Name
Mereo Research Site
City
Mohacs
Country
Hungary
Facility Name
Mereo Research Site
City
Naples
Country
Italy
Facility Name
Mereo Research Site
City
Daugavpils
Country
Latvia
Facility Name
Mereo Research Site
City
Riga
Country
Latvia
Facility Name
Mereo Research Site
City
Valmiera
Country
Latvia
Facility Name
Mereo Research Site
City
Chrzanow
Country
Poland
Facility Name
Mereo Research Site
City
Krakow
Country
Poland
Facility Name
Mereo Research Site
City
Proszowice
Country
Poland
Facility Name
Mereo Research Site
City
Wroclaw
Country
Poland
Facility Name
Mereo Research Site
City
Zgierz
Country
Poland
Facility Name
Mereo Research Site
City
Bucharest
Country
Romania
Facility Name
Mereo Research Site
City
Cluj Napoca
Country
Romania
Facility Name
Mereo Research Site
City
Constanta
Country
Romania
Facility Name
Mereo Research Site
City
Craiova
Country
Romania
Facility Name
Mereo Research Site
City
Marghita
Country
Romania
Facility Name
Mereo Research Site
City
Suceava
Country
Romania
Facility Name
Mereo Research Site
City
Timisoara
Country
Romania
Facility Name
Mereo Research Site
City
Izhevsk
Country
Russian Federation
Facility Name
Mereo Research Site
City
Kemerovo
Country
Russian Federation
Facility Name
Mereo Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Mereo Research Site
City
Saratov
Country
Russian Federation
Facility Name
Mereo Research Site
City
Tomsk
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

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