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Completed

NCT Number: NCT04091360

A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease

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).

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Respiratory Clinical Trials Ltd, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Part A: RPL554

Drug

Single dose RPL554 via metered dose inhaler.

Other names: Part A

Placebos

Drug

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: RPL554

Drug

Part B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.

Other names: Part B

Primary outcomes

  1. Part A: Pharmacokinetic Parameter AUC0-12

    Time frame: Day 1

    Area under the curve from 0 to 12 hours after single dose drug administration.

  2. Part A: Pharmacokinetic Parameter Cmax

    Time frame: Day 1

    Pharmacokinetic Parameter Cmax after a Single Dose

  3. 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

  4. Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)

    Time frame: Day 1

    RPL554 Plasma Pharmacokinetics concentration after single dose

  5. 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

Secondary outcomes

  1. Part A: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1 Dose

    Time frame: Day 1

    Change from Baseline FEV1 to Peak FEV1 (over 4 hours) After Single Dose

  2. Part A: Change From Baseline in Average FEV1 (Over 4 Hours) After 1 Dose

    Time frame: Day 1

    Change from Baseline FEV1 to Average FEV1 (over 4 hours) After Single Dose

  3. Part A: Change From Baseline in Average FEV1 (Over 12 Hours) After 1 Dose

    Time frame: Day 1

    Change from Baseline FEV1 to Average FEV1 (over 12 hours) After Single Dose

  4. Part A: Safety and Tolerability / Hematology Safety Assessments

    Time frame: 1 day

    Number of patients with treatment-emergent hematology abnormal laboratory assessments

  5. 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

  6. 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

  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: 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)

  9. 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

  10. 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

  11. Part B: Change From Baseline in Average FEV1 (Over 4 Hrs) After 7 Days

    Time frame: Day 7

    Change from baseline in average FEV1 (over 4 hours) on Day 7 after morning dose

  12. Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 7 Days

    Time frame: Day 7

    Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 7 after morning dose

  13. Part B: Change From Baseline in Trough FEV1 After 7 Days

    Time frame: Day 7

    Change from Baseline FEV1 to Morning Trough FEV1 on Day 7 after morning dose

  14. Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1st Dose

    Time frame: Day 1

    Change from baseline FEV1 in peak FEV1 (over 4 hours) after first dose

  15. Part B: Change From Baseline in Average FEV1 (Over 4 Hours) After 1st Dose

    Time frame: Day 1

    Change from baseline FEV1 in average FEV1 (over 4 hours) on Day 1

  16. Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 1st Dose

    Time frame: Day 1

    Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 1

  17. Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action)

    Time frame: Day 1

    Determination of onset of action (>10% increase in FEV1 from pre- to post-first dose, censored at 120 minutes) on Day 1

  18. Part B: Safety and Tolerability / Hematology Safety Assessments

    Time frame: 1 day

    Number of patients with treatment-emergent hematology abnormal laboratory assessments

  19. Part B: Safety and Tolerability / Blood Chemistry Safety Assessments

    Time frame: 1 day

    Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments

  20. Part B: Safety and Tolerability / Urinalysis Safety Assessments

    Time frame: 1 day

    Number of patients with treatment-emergent urinalysis abnormal laboratory assessments

  21. 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)

  22. 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)

  23. 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

  24. 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

Sponsors and collaborators

Lead sponsor

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 16, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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