Phase 2
Completed N=40
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT04091360 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Part A: Pharmacokinetic Parameter AUC0-12 — 175; 611; 1550; 5860 h*pg/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Pharmacokinetic Parameter AUC0-12 |
175; 611; 1550; 5860; 9360 | — |
| PRIMARY Part A: Pharmacokinetic Parameter Cmax |
39.4; 138; 467; 1520; 2360 | — |
| PRIMARY Part A: Pharmacokinetic Parameter AUC0-t |
208; 692; 1680; 6800; 10800 | — |
| PRIMARY Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life) |
6.31; 5.32; 3.47; 5.62; 4.44 | — |
| PRIMARY Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) on Day 7 |
0.189; 0.261; 0.310; -0.016 | <0.0001 sig |
| SECONDARY Part A: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1 Dose |
0.133; 0.264; 0.255; 0.332; 0.477; 0.086 | <0.0001 sig |
| SECONDARY Part A: Change From Baseline in Average FEV1 (Over 4 Hours) After 1 Dose |
0.058; 0.161; 0.153; 0.240; 0.334; -0.011 | <0.0001 sig |
| SECONDARY Part A: Change From Baseline in Average FEV1 (Over 12 Hours) After 1 Dose |
0.018; 0.061; 0.010; 0.121; 0.190; -0.031 | <0.0001 sig |
| SECONDARY Part A: Safety and Tolerability / Hematology Safety Assessments |
— | — |
| SECONDARY Part A: Safety and Tolerability / Blood Chemistry Safety Assessments: Number of Patients With Treatment-emergent Blood Chemistry Abnormal Laboratory Assessments |
— | — |
| SECONDARY Part A: Safety and Tolerability / Urinalysis Safety Assessments: Number of Patients With Treatment-emergent Urinalysis Abnormal Laboratory Assessments |
— | — |
| SECONDARY Part A: Safety and Tolerability / Supine Vitals Signs - Pulse Rate |
— | — |
| SECONDARY Part A: Safety and Tolerability / Supine Vitals Signs - Blood Pressure |
— | — |
| SECONDARY Part A: Safety and Tolerability / ECG - QTcF |
— | — |
| SECONDARY Part A: Safety and Tolerability / ECG - Heart Rate |
— | — |
| SECONDARY Part B: Change From Baseline in Average FEV1 (Over 4 Hrs) After 7 Days |
0.083; 0.161; 0.206; -0.095 | <0.0001 sig |
| SECONDARY Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 7 Days |
0.008; 0.075; 0.085; -0.112 | <0.0001 sig |
| SECONDARY Part B: Change From Baseline in Trough FEV1 After 7 Days |
-0.051; -0.017; 0.013; -0.097 | 0.0066 sig |
| SECONDARY Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1st Dose |
0.253; 0.311; 0.337; 0.079 | <0.0001 sig |
| SECONDARY Part B: Change From Baseline in Average FEV1 (Over 4 Hours) After 1st Dose |
0.144; 0.204; 0.224; -0.017 | <0.0001 sig |
| SECONDARY Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 1st Dose |
0.047; 0.102; 0.085; -0.058 | <0.0001 sig |
| SECONDARY Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action) |
37.0; 27.5; 19.0 | 0.47 |
| SECONDARY Part B: Safety and Tolerability / Hematology Safety Assessments |
— | — |
| SECONDARY Part B: Safety and Tolerability / Blood Chemistry Safety Assessments |
— | — |
| SECONDARY Part B: Safety and Tolerability / Urinalysis Safety Assessments |
— | — |
| SECONDARY Part B: Safety and Tolerability / Supine Vital Signs - Pulse Rate |
— | — |
| SECONDARY Part B: Safety and Tolerability / Supine Vital Signs - Blood Pressure |
— | — |
| SECONDARY Part B: Safety and Tolerability / ECG - QTcF |
— | — |
| SECONDARY Part B: Safety and Tolerability / ECG - Heart Rate |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04091360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.