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Also known as Salbutamol HFA-152a, Salbutamol HFA-134a
Ventolin · 4 trials · 3 indications
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
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 HFA-152a MDI | EXPERIMENTAL | Participants with asthma received inhalation of 200 microgram (ug) (2\*100 ug) or as needed up to maximum 800 µg once daily Salbutamol HFA-152a (Test) via metered dose inhaler (MDI) suspension at 30 second intervals per actuation. Participants attended 5 On-treatment visits at Weeks 0 (Day 1), 1, 4, 8 \& 12 and a Follow-up visit at Week 13. |
| Salbutamol HFA-134a MDI | ACTIVE_COMPARATOR | Participants with asthma received inhalation of 200 microgram (ug) (2\*100 ug) once daily plus as needed up to maximum 800 of µg Salbutamol HFA-134a (Reference) via metered dose inhaler (MDI) suspension at 30 second intervals per actuation. Participants attended 5 On-treatment visits at Weeks 0 (Day 1), 1, 4, 8 \& 12 and a Follow-up visit at Week 13. |
| 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...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Ventolin is used to treat asthma. It is a salbutamol metered dose inhaler developed by GSK plc. The current development program focuses on reformulating Ventolin with the propellant HFA-152a, studied in adults aged 18 and older with asthma, including mild asthma.
Ventolin is made by GSK plc, which trades under the ticker GSK. GSK is developing reformulated versions of Ventolin that use the propellant HFA-152a in place of HFA-134a, and the company is running the clinical program evaluating these inhaler formulations in asthma.
The Ventolin reformulation program has reached Phase 3. A Phase 3 study, NCT06261957, assessed three months of treatment with salbutamol via metered dose inhaler containing propellant HFA-152a or HFA-134a in 471 participants with asthma, and it is completed.
Ventolin has been studied in four trials. NCT06433921 is a recruiting Phase 1 relative potency study in mild asthmatics in the United Kingdom. Completed trials include the Phase 3 safety study NCT06261957, the pharmacokinetics study NCT06433908, and the Green VENTOLIN pharmacokinetics study NCT05791565.
Ventolin is also known as Salbutamol HFA-152a and Salbutamol HFA-134a. These names refer to salbutamol metered dose inhaler formulations that differ by propellant: HFA-152a is the test propellant and HFA-134a is the reference propellant used in the GSK clinical studies.
The Ventolin reformulations containing propellant HFA-152a are investigational and remain in clinical development, with a completed Phase 3 safety and tolerability study in asthma. The program has not reported an approval for these reformulated inhaler products.