| Primary | Part A: Pharmacokinetic Parameter AUC0-12 | Area under the curve from 0 to 12 hours after single dose drug administration. | Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group. | Posted | | Mean | Standard Deviation | h*pg/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg | Single dose of RPL554 via pMDI (single-blind) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000175± 96.7
- OG001611± 183
- OG0021550± 443
- OG003
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| Primary | Part A: Pharmacokinetic Parameter Cmax | Pharmacokinetic Parameter Cmax after a Single Dose | Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group. | Posted | | Mean | Standard Deviation | pg/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg | |
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| Primary | Part A: Pharmacokinetic Parameter AUC0-t | Area under the curve at maximum concentration 0-24 hrs after single dose drug administration | Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group. | Posted | | Mean | Standard Deviation | h*pg/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg |
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| Primary | Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life) | RPL554 Plasma Pharmacokinetics concentration after single dose | Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group. | Posted | | Mean | Standard Deviation | h | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg | |
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| Primary | 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 | Full Analysis Set = number of patients with at least one on treatment value who contributed to the model estimation. | Posted | | Mean | Standard Deviation | L | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | Full analysis includes patients with values at baseline and peak FEV1 (0-4h). | Posted | | Mean | Standard Deviation | L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg | Single dose of RPL554 via pMDI (single-blind) | |
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| Secondary | 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 | Full analysis set. () () () () () () | Posted | | Mean | Standard Deviation | L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg | Single dose of RPL554 via pMDI (single-blind) | | OG005 |
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| Secondary | 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 | | Posted | | Mean | Standard Deviation | L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.10 mg | Single dose of RPL554 via pMDI (double-blind) | | OG001 | 0.30 mg | Single dose of RPL554 via pMDI (double-blind) | | OG002 | 1 mg | Single dose of RPL554 via pMDI (double-blind) | | OG003 | 3 mg | Single dose of RPL554 via pMDI (double-blind) | | OG004 | 6 mg | Single dose of RPL554 via pMDI (single-blind) | | OG005 |
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| Secondary | Part A: Safety and Tolerability / Hematology Safety Assessments | Number of patients with treatment-emergent hematology abnormal laboratory assessments | | Not Posted | | | | | | 1 day | | Participants | | | | |
| Secondary | 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 | | Not Posted | | | | | | 1 day | | Participants | | | | |
| Secondary | 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 | | Not Posted | | | | | | 1 day | | Participants | | | | |
| Secondary | Part A: Safety and Tolerability / Supine Vitals Signs - Pulse Rate | Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm) | | Not Posted | | | | | | Start of treatment to day 1 | | Participants | | | | |
| Secondary | Part A: Safety and Tolerability / Supine Vitals Signs - Blood Pressure | Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg) | | Not Posted | | | | | | Start of treatment to day 1 | | Participants | | | | |
| Secondary | Part A: Safety and Tolerability / ECG - QTcF | Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec | | Not Posted | | | | | | Start of treatment to day 1 | | Participants | | | | |
| Secondary | Part A: Safety and Tolerability / ECG - Heart Rate | Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm | | Not Posted | | | | | | Start of treatment to day 1 | | Participants | | | | |
| Secondary | 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 | | Posted | | Mean | Standard Deviation | L | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | | Posted | | Mean | Standard Deviation | L | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | | Posted | | Mean | Standard Deviation | L | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | | Posted | | Mean | Standard Deviation | L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | | Posted | | Mean | Standard Deviation | L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | number of patients with at least one on treatment value who contributed to the model. | Posted | | Mean | Standard Deviation | L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG003 | Placebo | 7 day, twice daily dose of placebo via MPI (double-blind) complete block, cross-over |
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| Secondary | 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 | Patients with onset of action | Posted | | Median | Full Range | mins | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 0.30 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG001 | 1 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over | | OG002 | 3 mg | 7 day, twice daily dose of RPL554 via MPI (double-blind) complete block, cross-over |
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| Secondary | Part B: Safety and Tolerability / Hematology Safety Assessments | Number of patients with treatment-emergent hematology abnormal laboratory assessments | | Not Posted | | | | | | 1 day | | Participants | | | | |
| Secondary | Part B: Safety and Tolerability / Blood Chemistry Safety Assessments | Number of patients with treatment-emergent blood chemistry abnormal laboratory assessments | | Not Posted | | | | | | 1 day | | Participants | | | | |
| Secondary | Part B: Safety and Tolerability / Urinalysis Safety Assessments | Number of patients with treatment-emergent urinalysis abnormal laboratory assessments | | Not Posted | | | | | | 1 day | | Participants | | | | |
| Secondary | Part B: Safety and Tolerability / Supine Vital Signs - Pulse Rate | Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm) | | Not Posted | | | | | | Start of treatment to day 1 | | Participants | | | | |
| Secondary | Part B: Safety and Tolerability / Supine Vital Signs - Blood Pressure | Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg) | | Not Posted | | | | | | Start of treatment to day 1 | | Participants | | | | |
| Secondary | Part B: Safety and Tolerability / ECG - QTcF | Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec | | Not Posted | | | | | | Start of treatment to day 70 | | Participants | | | | |
| Secondary | Part B: Safety and Tolerability / ECG - Heart Rate | Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm | | Not Posted | | | | | | Start of treatment to day 70 | | Participants | | | | |