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Trial record 4 of 10 for:    ensifentrine | Phase 2
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A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT04091360
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Verona Pharma plc

Study Description
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Brief Summary:
The purpose of this study is to find the best dose of RPL554 for treating the symptoms of COPD. COPD is a progressive disease that effects the lungs. In this study single doses will be given in the Part A of the study. The information from Part A will be used to decide the best doses to be used in Part B. In this part, patients will take 4-5 different doses, each for a week to decide which dose best treats the symptoms of COPD.

Condition or disease Intervention/treatment Phase
COPD Drug: Ensifentrine 100mcg Drug: Ensifentrine 300mcg Drug: Ensifentrine 1000mcg Drug: Ensifentrine 3000mcg Drug: Ensifentrine 6000mcg Drug: Placebos Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental dose 1 - 100ug

Patients will be randomly assigned to receive a single dose of one of six possible treatments. For Treatment Arm 1; each patient will be instructed to take two puffs (inhalations) from each of Inhalers 1 through 3, for a total of six inhalations.

No. of Puffs per Inhaler = 2; Total Dose = 100ug; Inhaler No.1 = 50ug; Inhaler No.2 = Placebo; Inhaler No.3 =Placebo

 Drug: Ensifentrine 100mcg

Single doses of RPL554 inhaled via pressurised metered dose inhaler:

Doses are - 100mcg

Other Name: RPL554
Experimental: Experimental dose 2 - 300ug

Patients will be randomly assigned to receive a single dose of one of six possible treatments. For Treatment Arm 2; each patient will be instructed to take two puffs (inhalations) from each of Inhalers 1 through 3, for a total of six inhalations.

No. of Puffs per Inhaler = 2; Total Dose = 300ug; Inhaler No.1 = 150ug; Inhaler No.2 = Placebo; Inhaler No.3 =Placebo

 Drug: Ensifentrine 300mcg

Single doses of RPL554 inhaled via pressurised metered dose inhaler:

Doses are - 300mcg

Other Name: RPL554
Experimental: Experimental dose 3 - 1000ug

Patients will be randomly assigned to receive a single dose of one of six possible treatments. For Treatment Arm 3; each patient will be instructed to take two puffs (inhalations) from each of Inhalers 1 through 3, for a total of six inhalations.

No. of Puffs per Inhaler = 2; Total Dose = 1000ug; Inhaler No.1 = 500ug; Inhaler No.2 = Placebo; Inhaler No.3 =Placebo

 Drug: Ensifentrine 1000mcg
single doses of RPL554 inhaled via pressurised metered dose inhaler: Doses are - 1000mcg
Other Name: RPL554
Experimental: Experimental dose 4 - 3000ug

Patients will be randomly assigned to receive a single dose of one of six possible treatments. For Treatment Arm 4; each patient will be instructed to take two puffs (inhalations) from each of Inhalers 1 through 3, for a total of six inhalations.

No. of Puffs per Inhaler = 2; Total Dose = 3000ug; Inhaler No.1 = 500ug; Inhaler No.2 = 500ug; Inhaler No.3 = 500ug

 Drug: Ensifentrine 3000mcg

Single doses of RPL554 inhaled via pressurised metered dose inhaler:

Doses are - 3000mcg

Other Name: RPL554
Experimental: Experimental dose 5 - 6000ug

Patients will be randomly assigned to receive a single dose of one of six possible treatments. For Treatment Arm 5; each patient will be instructed to take four puffs (inhalations) from each of Inhalers 1 through 3, for a total of twelve inhalations.

No. of Puffs per Inhaler = 4; Total Dose = 6000ug; Inhaler No.1 = 500ug; Inhaler No.2 = 500ug; Inhaler No.3 = 500ug

 Drug: Ensifentrine 6000mcg

Single doses of RPL554 inhaled via pressurised metered dose inhaler:

Doses are - 6000mcg

Other Name: RPL554
Placebo Comparator: Placebo comparator - placebo

Patients will be randomly assigned to receive a single dose of one of six possible treatments. For Treatment Arm 6; each patient will be instructed to take two puffs (inhalations) from each of Inhalers 1 through 3, for a total of six inhalations.

No. of Puffs per Inhaler = 2; Total Dose = Placebo; Inhaler No.1 = Placebo; Inhaler No.2 = Placebo; Inhaler No.3 = Placebo

 Drug: Placebos

Single doses of Placebo inhaled via pressurised metered dose inhaler:

Doses are - Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Pharmacokinetic parameter AUC0-12 [ Time Frame: 12 hours ]
    Area under the curve from 0 to 12 hours after drug administration.

  2. Part A: Pharmacokinetic parameter AUC0-t [ Time Frame: 1 day ]
    Area under the curve at maximum concentration

  3. Part A: Pharmacokinetic parameter half-life [ Time Frame: 1 day ]
    Half-life

  4. Part B: Peak FEV1 (forced expiratory volume) [ Time Frame: Baseline to treatment period 5 day 7, which is approximately 70 days ]
    Change from baseline in Peak FEV1 measured after morning dosing on Day 7


Secondary Outcome Measures :
  1. Part A: Safety and tolerability / Hematology Safety Assessments [ Time Frame: 1 day ]
    Number of patients with treatment-emergent hematology abnormal laboratory assessments

  2. Part A: Safety and tolerability / Blood Chemistry Safety Assessments: Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments [ Time Frame: 1 day ]
    Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments

  3. Part A: Safety and tolerability / Urinalysis Safety Assessments: Number of patients with treatment-emergent urinalysis abnormal laboratory assessments [ Time Frame: 1 day ]
    Number of patients with treatment-emergent urinalysis abnormal laboratory assessments

  4. Part A: Safety and tolerability / ECG - QTcF [ Time Frame: Start of treatment to day 1 ]
    Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec

  5. Part A: Safety and tolerability / ECG - Heart Rate [ Time Frame: Start of treatment to day 1 ]
    Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm

  6. Part A: Safety and tolerability / Supine vitals signs - Blood pressure [ Time Frame: Start of treatment to day 1 ]
    Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg)

  7. Part A: Safety and tolerability / Supine vitals signs - Pulse rate [ Time Frame: Start of treatment to day 1 ]
    Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm)

  8. Part A: Average AUC FEV1 Change from baseline (forced expiratory volume) [ Time Frame: Start of treatment to day 1 ]
    Change from baseline in average area under the curve 0-4 hours first forced expiratory volume after single dose

  9. Part A: Average AUC FEV1 Change from baseline (forced expiratory volume) [ Time Frame: 12 hours ]
    Change from baseline in average area under the curve 0-12 hours first forced expiratory volume after single dose

  10. Part A: Peak FEV1 Change from baseline after single dose [ Time Frame: Start of treatment to day 1 ]
    Change from baseline in peak first forced expiratory volume after single dose

  11. Part B: Safety and tolerability / Hematology safety assessments [ Time Frame: 1 day ]
    Number of patients with treatment-emergent hematology abnormal laboratory assessments

  12. Part B: Safety and tolerability / Blood chemistry safety assessments [ Time Frame: 1 day ]
    Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments

  13. Part B: Safety and tolerability / Urinalysis safety assessments [ Time Frame: 1 day ]
    Number of patients with treatment-emergent urinalysis abnormal laboratory assessments

  14. Part B: Safety and tolerability / ECG - QTcF [ Time Frame: Start of treatment to day 70 ]
    Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec

  15. Part B: Safety and tolerability / ECG - Heart rate [ Time Frame: Start of treatment to day 70 ]
    Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm

  16. Part B: Safety and tolerability / Supine vital signs - Blood pressure [ Time Frame: Start of treatment to day 1 ]
    Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg)

  17. Part B: Safety and tolerability / Supine vital signs - Pulse rate [ Time Frame: Start of treatment to day 1 ]
    Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm)

  18. Part B: Change from baseline in trough FEV1 [ Time Frame: Day 7 ]
    Change from baseline in morning trough first forced expiratory volume at day 7


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients must be clinically stable without recent COPD exacerbations or hospitalisations.
  • They must not have uncontrolled disease or chronic heart failure.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091360


Contacts
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Contact: Reynold Daniel, B.S. 914-860-6855 reynold.daniel@veronapharma.com

Locations
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United Kingdom
Respiratory Clinical Trials Ltd Recruiting
London, United Kingdom, W1G 8HU
Contact: Brian Leaker    +44 207 034 3324    brian.leaker@heartlungcentre.com   
Medicines Evaluation Unit Limited Recruiting
Wythenshawe, United Kingdom, M23 9QZ
Contact: David Singh    +44 161 946 4050    dsingh@meu.org.uk   
Sponsors and Collaborators
Verona Pharma plc
Iqvia Pty Ltd
More Information
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Responsible Party: Verona Pharma plc
ClinicalTrials.gov Identifier: NCT04091360    
Other Study ID Numbers: RPL554-MD-201
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verona Pharma plc:
COPD
Adults
Phase II
RPL554
Ensifentrine