Chronic Obstructive Pulmonary DiseasePhase 2NCT01332097

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

A Phase 2 study testing BCT197 and Prednisone in people with Chronic Obstructive Pulmonary Disease, run by Mereo BioPharma at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: BCT197 and Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 183 participants
Where: 6 sitesin 3 countries
Study dates: Mar 2011to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

Russia3 sites

Novartis Investigative Site
Moscow, 107014
Novartis Investigative Site
Moscow, 117292
Novartis Investigative Site
Saint Petersburg, 191015

Other trials in Russia

Bulgaria2 sites

Novartis Investigative Site
Plovdiv, 4000
Novartis Investigative Site
Rousse, 7002

Other trials in Bulgaria

Romania1 site

Novartis Investigative Site
Bucharest, 50159

Other trials in Romania

About this study

Official title: An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation

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.

Read the detailed description

This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive parallel-group design study in four parts in patients with acute COPD exacerbation. In Part I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II received their single dose on Day 1 of the study. In Parts III and IV patients were randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III) or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the study.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: BCT197, Prednisone placebo, BCT197 placebo, Prednisone
Keywords: Chronic Obstructive Pulmonary Disease, Exacerbation, Pulmonary Inflammation
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCT197Drug
Prednisone placeboDrug
capsules
BCT197 placeboDrug
capsules
PrednisoneDrug
capsules

Study groups in NCT01332097
Study group	Role	What they receive
Treatment A	Experimental	Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules Receives: Drug: BCT197; Drug: Prednisone placebo
Treatment B/G/E/I	Placebo comparator	Matching placebo comparator arm Receives: Drug: Prednisone placebo; Drug: BCT197 placebo
Treatment C	Active comparator	Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules Receives: Drug: BCT197 placebo; Drug: Prednisone
Treatment D	Experimental	Single oral dose of 20mg dose of BCT197 capsules Receives: Drug: BCT197
Treatment F	Experimental	Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 Receives: Drug: BCT197
Treatment H	Experimental	Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6 Receives: Drug: BCT197

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL
Measure: FEV1
Change in Forced Expiry Volume in 1 second
Measured: Day 5, Day 10

Secondary outcomes (1)

Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO
EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study.
Measured: Up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011May 2013

First posted8 Apr 2011 (estimated)
Study startMar 2011
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332097
Sponsor's protocol ID: CBCT197A2201
Other IDs: 2010-021723-27
Status last verified: Feb 2023
First submitted: 7 Apr 2011
Last updated: 21 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Strambu IR, Kobalava ZD, Magnusson BP, MacKinnon A, Parkin JM. Phase II Study of Single/Repeated Doses of Acumapimod (BCT197) to Treat Acute Exacerbations of COPD. COPD. 2019 Dec;16(5-6):344-353. doi: 10.1080/15412555.2019.1682535. Epub 2019 Nov 4.
PubMed 31682162

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation
ClinicalTrials.gov ID: NCT01332097
Acronym / sponsor ID: CBCT197A2201
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, Exacerbation, Pulmonary Inflammation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Mereo BioPharmaIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Mar 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 8 Apr 2011 (estimated)
Results: Posted 21 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Treatment A	Experimental	Drug: BCT197, Drug: Prednisone placeboSingle 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
Treatment B/G/E/I	Placebo comparator	Drug: Prednisone placebo, Drug: BCT197 placeboMatching placebo comparator arm
Treatment C	Active comparator	Drug: BCT197 placebo, Drug: PrednisoneSingle oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Treatment D	Experimental	Drug: BCT197Single oral dose of 20mg dose of BCT197 capsules
Treatment F	Experimental	Drug: BCT197Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
Treatment H	Experimental	Drug: BCT197Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BCT197	Drug	Treatment A, Treatment D, Treatment F, Treatment H
Prednisone placebocapsules	Drug	Treatment A, Treatment B/G/E/I
BCT197 placebocapsules	Drug	Treatment B/G/E/I, Treatment C
Prednisonecapsules	Drug	Treatment C

Primary outcome

Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
Time frame: Day 5, Day 10
Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL Measure: FEV1 Change in Forced Expiry Volume in 1 second

1 secondary outcome

Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO
Time frame: Up to Day 29

Results and safety

Results posted to the registry on 21 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A	31	30
Treatment C	30	26
Treatment D	25	23
Treatment F	27	24
Treatment H	25	22
Treatment B,E,G I	45	44

Primary outcome: Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second

Time frame: Day 5, Day 10. Least squares mean (95% Confidence Interval). Unit: mL

Measure	Treatment A n = 30	Treatment B, E, G & I n = 45	Treatment C n = 30	Treatment D n = 25	Treatment F n = 26	Treatment H n = 25
Day 5	155.1 (80.8 to 229.3)	100.8 (40.0 to 161.7)	48.9 (-25.6 to 123.3)	106.3 (24.7 to 187.9)	134.4 (54.6 to 214.1)	200.6 (119.0 to 282.3)
Day 10	164.6 (51.0 to 278.3)	126.9 (37.0 to 216.8)	54.9 (-56.8 to 166.7)	54.6 (-88.8 to 198.0)	109.0 (5.6 to 212.5)	250.5 (144.5 to 356.4)

Treatment A vs Treatment B, E, G & I: Least squares mean difference: 54.2 (95% CI -41.7 to 150.1)
Treatment B, E, G & I vs Treatment C: Least squares mean difference: -52.0 (95% CI -148.5 to 44.5)
Treatment B, E, G & I vs Treatment D: Least squares mean difference: 5.5 (95% CI -96.0 to 106.9)

Population analysed: The PD analysis set included all participants without major protocol deviations that impacted efficacy/pharmacodynamic data. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number analyzed" is the number of participants evaluated at each time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	2 of 31 (6.5%)	5 of 31 (16.1%)	1 of 31
Treatment B, E, G & I	4 of 45 (8.9%)	20 of 45 (44.4%)	0 of 45
Treatment C	5 of 30 (16.7%)	16 of 30 (53.3%)	2 of 30
Treatment D	2 of 25 (8%)	13 of 25 (52%)	1 of 25
Treatment F	3 of 27 (11.1%)	14 of 27 (51.9%)	1 of 27
Treatment H	3 of 25 (12%)	16 of 25 (64%)	1 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31682162Strambu IR, Kobalava ZD, Magnusson BP, MacKinnon A, Parkin JM. Phase II Study of Single/Repeated Doses of Acumapimod (BCT197) to Treat Acute Exacerbations of COPD. COPD. 2019 Dec;16(5-6):344-353. doi: 10.1080/15412555.2019.1682535. Epub 2019 Nov 4.
Individual participant dataSharing planned: No

Related trials for Chronic Obstructive Pulmonary Disease

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacqueline Parkin, PhD FRCP study director

Mereo BioPharma

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCT197 and Prednisone in people with Chronic Obstructive Pulmonary Disease, run by Mereo BioPharma at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia, Bulgaria, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second (time frame: Day 5, Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01332097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.