Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Salbutamol HFA-152a, Salbutamol HFA-134a
Ventolin · 4 trials · 3 indications
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Salbutamol Test Arm | EXPERIMENTAL | - |
| Salbutamol Reference Arm | ACTIVE_COMPARATOR | - |
| Part 1 | EXPERIMENTAL | Part 1 will consist of a 7 treatment, 7 period cross-over evaluation with all participants receiving the following treatments once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period. |
| Part 2 | EXPERIMENTAL | Part 2 will consist of a 7 treatment, 7-way cross-over with all participants receiving the following treatments given once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 3-day and maximum of a 7-day methacholine washout will separate each treatment period. |
| Cohort 1: Salbutamol 200 μg | EXPERIMENTAL | Participants will receive single 200 μg doses given as 2x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10. |
| Cohort 2: Salbutamol 800 μg | EXPERIMENTAL | Participants will receive single 800 μg doses given as 8x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10. |
| Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI | EXPERIMENTAL | Participants will receive Salbutamol HFA-152a MDI in treatment period 1 followed by Salbutamol HFA-134a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period. |
| Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI | EXPERIMENTAL | Participants will receive Salbutamol HFA-134a MDI in treatment period 1 followed by Salbutamol HFA-152a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Salbutamol HFA-134a | DRUG | 100 microgram (μg) (ex-valve) at 30-second intervals per actuation |
| Salbutamol HFA-152a | DRUG | 100 μg (ex-valve) at 30-second intervals per actuation |
| Placebo | DRUG | A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals. |
Inclusion Criteria: 1. Participant of ≥18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian. 2. Asthma for ≥ 6 months, defined as: * Documented history of asthma, as defined by Global Initiative for Asth...