COPDPhase 2NCT04091360
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Part A: RPL554 and Part B: RPL554 in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Part A: RPL554 and Part B: RPL554
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 Apr 2019to 21 Jan 2021
- 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
- Male and female patients with moderate to severe COPD, with a post bronchodilator FEV1 of 40 to 80% of predicted and FEV1/FVC ratio of ≤0.70.
- They must have a baseline increase in FEV1 of >150 mL following four puffs of salbutamol.
- They must have at least a 10 pack-year smoking history, and may be either a current or former smoker.
Who cannot join
- Patients must be clinically stable without recent COPD exacerbations or hospitalisations.
- They must not have uncontrolled disease or chronic heart failure.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Respiratory Clinical Trials Ltd
London, W1G 8HU
Medicines Evaluation Unit Limited
Wythenshawe, M23 9QZ
About this study
Official title: A Phase II, Randomised Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Pressurised Metered Dose Inhaler in Patients With COPD
The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Read the detailed description
The study will consist of two parts. Part A is a parallel group, placebo-controlled single dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect of a single dose of RPL554 administered via pMDI. Five of the 6 treatment arms will be double-blind and one will be single-blind (due to the different number of capsules administered). Part B is a 7-day placebo-controlled, complete block cross-over, repeat dose study to assess the bronchodilator effect of repeat doses of RPL554 delivered via pMDI.
- Conditions
- COPD
- Being tested
- Part A: RPL554, Placebos, Part B: RPL554
- Keywords
- COPD, Adults, Phase II, RPL554, Ensifentrine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A: RPL554Drug
Also called Part A
Single dose RPL554 via metered dose inhaler.
PlacebosDrug
Part A: Single dose placebo via metered dose inhaler. Part B: Repeat doses of placebo via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.
Part B: RPL554Drug
Also called Part B
Part B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| RPL554 100 mcg | Experimental | Part A: Patients receive 1 dose of either RPL554 100mcg via metered dose inhaler.
Part B: not applicable Receives: Drug: Part A: RPL554; Drug: Placebos |
| RPL554 300 mcg | Experimental | Part A: Patients receive 1 dose of RPL554 300mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 300mcg via metered dose inhaler in crossover fashion. Receives: Drug: Part A: RPL554; Drug: Placebos; Drug: Part B: RPL554 |
| RPL554 1000 mcg | Experimental | Part A: Patients receive 1 dose of RPL554 1000mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 3000mcg via metered dose inhaler in crossover fashion. Receives: Drug: Part A: RPL554; Drug: Placebos; Drug: Part B: RPL554 |
| RPL554 3000 mcg | Experimental | Part A: Patients receive 1 dose of either RPL554 3000mcg via metered dose inhaler.
Part B: Patients receive repeat doses of RPL554 3000mcg via metered dose inhaler in crossover fashion. Receives: Drug: Part A: RPL554; Drug: Placebos; Drug: Part B: RPL554 |
| RPL554 6000 mcg | Experimental | Part A: Patients receive 1 dose of either RPL554 6000mcg via metered dose inhaler.
Part B: not applicable Receives: Drug: Part A: RPL554; Drug: Placebos |
| RPL554 Placebo | Placebo comparator | Part A: Patients receive 1 dose of RPL554 placebo via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 placebo via metered dose inhaler in crossover fashion. Receives: Drug: Part A: RPL554; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Pharmacokinetic Parameter AUC0-12
Area under the curve from 0 to 12 hours after single dose drug administration.
Measured: Day 1
Part A: Pharmacokinetic Parameter Cmax
Pharmacokinetic Parameter Cmax after a Single Dose
Measured: Day 1
Part A: Pharmacokinetic Parameter AUC0-t
Area under the curve at maximum concentration 0-24 hrs after single dose drug administration
Measured: Day 1
Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)
RPL554 Plasma Pharmacokinetics concentration after single dose
Measured: Day 1
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) on Day 7
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) after morning dosing on Day 7
Measured: Day 7
Secondary outcomes (24)
Part A: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1 Dose
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) After Single Dose
Measured: Day 1
Part A: Change From Baseline in Average FEV1 (Over 4 Hours) After 1 Dose
Change from Baseline FEV1 to Average FEV1 (over 4 hours) After Single Dose
Measured: Day 1
Part A: Change From Baseline in Average FEV1 (Over 12 Hours) After 1 Dose
Change from Baseline FEV1 to Average FEV1 (over 12 hours) After Single Dose
Measured: Day 1
Part A: Safety and Tolerability / Hematology Safety Assessments
Number of patients with treatment-emergent hematology abnormal laboratory assessments
Measured: 1 day
Part A: Safety and Tolerability / Blood Chemistry Safety Assessments: Number of Patients With Treatment-emergent Blood Chemistry Abnormal Laboratory Assessments
Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments
Measured: 1 day
Part A: Safety and Tolerability / Urinalysis Safety Assessments: Number of Patients With Treatment-emergent Urinalysis Abnormal Laboratory Assessments
Number of patients with treatment-emergent urinalysis abnormal laboratory assessments
Measured: 1 day
Part A: Safety and Tolerability / Supine Vitals Signs - Pulse Rate
Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm)
Measured: Start of treatment to day 1
Part A: Safety and Tolerability / Supine Vitals Signs - Blood Pressure
Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg)
Measured: Start of treatment to day 1
Part A: Safety and Tolerability / ECG - QTcF
Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec
Measured: Start of treatment to day 1
Part A: Safety and Tolerability / ECG - Heart Rate
Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm
Measured: Start of treatment to day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hrs) After 7 Days
Change from baseline in average FEV1 (over 4 hours) on Day 7 after morning dose
Measured: Day 7
Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 7 Days
Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 7 after morning dose
Measured: Day 7
Part B: Change From Baseline in Trough FEV1 After 7 Days
Change from Baseline FEV1 to Morning Trough FEV1 on Day 7 after morning dose
Measured: Day 7
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1st Dose
Change from baseline FEV1 in peak FEV1 (over 4 hours) after first dose
Measured: Day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hours) After 1st Dose
Change from baseline FEV1 in average FEV1 (over 4 hours) on Day 1
Measured: Day 1
Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 1st Dose
Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 1
Measured: Day 1
Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action)
Determination of onset of action (>10% increase in FEV1 from pre- to post-first dose, censored at 120 minutes) on Day 1
Measured: Day 1
Part B: Safety and Tolerability / Hematology Safety Assessments
Number of patients with treatment-emergent hematology abnormal laboratory assessments
Measured: 1 day
Part B: Safety and Tolerability / Blood Chemistry Safety Assessments
Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments
Measured: 1 day
Part B: Safety and Tolerability / Urinalysis Safety Assessments
Number of patients with treatment-emergent urinalysis abnormal laboratory assessments
Measured: 1 day
Part B: Safety and Tolerability / Supine Vital Signs - Pulse Rate
Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm)
Measured: Start of treatment to day 1
Part B: Safety and Tolerability / Supine Vital Signs - Blood Pressure
Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg)
Measured: Start of treatment to day 1
Part B: Safety and Tolerability / ECG - QTcF
Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec
Measured: Start of treatment to day 70
Part B: Safety and Tolerability / ECG - Heart Rate
Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm
Measured: Start of treatment to day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start29 Apr 2019
- Primary completion10 Dec 2020
- Study completion21 Jan 2021
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.
- Other trials for COPDStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091360
- Sponsor's protocol ID
- RPL554-MD-201
- Status last verified
- Aug 2022
- First submitted
- 20 Jun 2019
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Pressurised Metered Dose Inhaler in Patients With COPD
- ClinicalTrials.gov ID
- NCT04091360
- Acronym / sponsor ID
- RPL554-MD-201
- Conditions
- COPD
- Keywords
- COPD, Adults, Phase II, RPL554, Ensifentrine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 25 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed description
The study will consist of two parts. Part A is a parallel group, placebo-controlled single dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect of a single dose of RPL554 administered via pMDI. Five of the 6 treatment arms will be double-blind and one will be single-blind (due to the different number of capsules administered). Part B is a 7-day placebo-controlled, complete block cross-over, repeat dose study to assess the bronchodilator effect of repeat doses of RPL554 delivered via pMDI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RPL554 100 mcg | Experimental | Drug: Part A: RPL554, Drug: PlacebosPart A: Patients receive 1 dose of either RPL554 100mcg via metered dose inhaler. Part B: not applicable |
| RPL554 300 mcg | Experimental | Drug: Part A: RPL554, Drug: Placebos, Drug: Part B: RPL554Part A: Patients receive 1 dose of RPL554 300mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 300mcg via metered dose inhaler in crossover fashion. |
| RPL554 1000 mcg | Experimental | Drug: Part A: RPL554, Drug: Placebos, Drug: Part B: RPL554Part A: Patients receive 1 dose of RPL554 1000mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 3000mcg via metered dose inhaler in crossover fashion. |
| RPL554 3000 mcg | Experimental | Drug: Part A: RPL554, Drug: Placebos, Drug: Part B: RPL554Part A: Patients receive 1 dose of either RPL554 3000mcg via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 3000mcg via metered dose inhaler in crossover fashion. |
| RPL554 6000 mcg | Experimental | Drug: Part A: RPL554, Drug: PlacebosPart A: Patients receive 1 dose of either RPL554 6000mcg via metered dose inhaler. Part B: not applicable |
| RPL554 Placebo | Placebo comparator | Drug: Part A: RPL554, Drug: PlacebosPart A: Patients receive 1 dose of RPL554 placebo via metered dose inhaler. Part B: Patients receive repeat doses of RPL554 placebo via metered dose inhaler in crossover fashion. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients with moderate to severe COPD, with a post bronchodilator FEV1 of 40 to 80% of predicted and FEV1/FVC ratio of ≤0.70.
- They must have a baseline increase in FEV1 of >150 mL following four puffs of salbutamol.
- They must have at least a 10 pack-year smoking history, and may be either a current or former smoker.
Key exclusion criteria (2 listed)
- Patients must be clinically stable without recent COPD exacerbations or hospitalisations.
- They must not have uncontrolled disease or chronic heart failure.
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 |
|---|---|---|
| Part A: RPL554Also: Part ASingle dose RPL554 via metered dose inhaler. | Drug | RPL554 100 mcg, RPL554 1000 mcg, RPL554 300 mcg, RPL554 3000 mcg, RPL554 6000 mcg, RPL554 Placebo |
| PlacebosPart A: Single dose placebo via metered dose inhaler. Part B: Repeat doses of placebo via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days. | Drug | RPL554 100 mcg, RPL554 1000 mcg, RPL554 300 mcg, RPL554 3000 mcg, RPL554 6000 mcg, RPL554 Placebo |
| Part B: RPL554Also: Part BPart B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days. | Drug | RPL554 1000 mcg, RPL554 300 mcg, RPL554 3000 mcg |
Primary outcome
Part A: Pharmacokinetic Parameter AUC0-12
Time frame: Day 1
Area under the curve from 0 to 12 hours after single dose drug administration.
Part A: Pharmacokinetic Parameter Cmax
Time frame: Day 1
Pharmacokinetic Parameter Cmax after a Single Dose
Part A: Pharmacokinetic Parameter AUC0-t
Time frame: Day 1
Area under the curve at maximum concentration 0-24 hrs after single dose drug administration
Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)
Time frame: Day 1
RPL554 Plasma Pharmacokinetics concentration after single dose
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) on Day 7
Time frame: Day 7
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) after morning dosing on Day 7
24 secondary outcomes
Part A: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1 Dose
Time frame: Day 1
Part A: Change From Baseline in Average FEV1 (Over 4 Hours) After 1 Dose
Time frame: Day 1
Part A: Change From Baseline in Average FEV1 (Over 12 Hours) After 1 Dose
Time frame: Day 1
Part A: Safety and Tolerability / Hematology Safety Assessments
Time frame: 1 day
Part A: Safety and Tolerability / Blood Chemistry Safety Assessments: Number of Patients With Treatment-emergent Blood Chemistry Abnormal Laboratory Assessments
Time frame: 1 day
Part A: Safety and Tolerability / Urinalysis Safety Assessments: Number of Patients With Treatment-emergent Urinalysis Abnormal Laboratory Assessments
Time frame: 1 day
Part A: Safety and Tolerability / Supine Vitals Signs - Pulse Rate
Time frame: Start of treatment to day 1
Part A: Safety and Tolerability / Supine Vitals Signs - Blood Pressure
Time frame: Start of treatment to day 1
Part A: Safety and Tolerability / ECG - QTcF
Time frame: Start of treatment to day 1
Part A: Safety and Tolerability / ECG - Heart Rate
Time frame: Start of treatment to day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hrs) After 7 Days
Time frame: Day 7
Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 7 Days
Time frame: Day 7
Part B: Change From Baseline in Trough FEV1 After 7 Days
Time frame: Day 7
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1st Dose
Time frame: Day 1
Part B: Change From Baseline in Average FEV1 (Over 4 Hours) After 1st Dose
Time frame: Day 1
Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 1st Dose
Time frame: Day 1
Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action)
Time frame: Day 1
Part B: Safety and Tolerability / Hematology Safety Assessments
Time frame: 1 day
Part B: Safety and Tolerability / Blood Chemistry Safety Assessments
Time frame: 1 day
Part B: Safety and Tolerability / Urinalysis Safety Assessments
Time frame: 1 day
Part B: Safety and Tolerability / Supine Vital Signs - Pulse Rate
Time frame: Start of treatment to day 1
Part B: Safety and Tolerability / Supine Vital Signs - Blood Pressure
Time frame: Start of treatment to day 1
Part B: Safety and Tolerability / ECG - QTcF
Time frame: Start of treatment to day 70
Part B: Safety and Tolerability / ECG - Heart Rate
Time frame: Start of treatment to day 70
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Part A: RPL554 and Part B: RPL554 in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 2 sites in United Kingdom.
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 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 25 Jul 2022). 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?
Part A: Pharmacokinetic Parameter AUC0-12 (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2022.