Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511220-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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:
A minimum of a 3-day and maximum of a 7-day methacholine washout will separate each treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol HFA-152a | Drug | A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20) | Up to 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 & Part 2: Peak QTc Interval | Up to 11 weeks | |
| Part 1 & Part 2: Peak Heart Rate (HR) | Up to 11 weeks | |
| Part 1 & Part 2: Minimum Serum Potassium |
Not provided
Inclusion Criteria:
4. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.
iii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA [GINA, 2023]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.
6. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
7. Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg/mL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods).
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.
11. Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
12. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.
Exclusion Criteria:
Medical Conditions
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.
Participants who are currently or in the last 15 days have worked nightshifts.
Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females.
A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.
Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of the study.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Manchester | M23 9QZ | United Kingdom |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
2-part, 7-way cross- over (Part 1 and Part 2)
Not provided
Not provided
Click here to enter text.
| Salbutamol HFA-134a | Drug | A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals. |
|
| Placebo | Drug | A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals. |
|
| Up to 11 weeks |
| Part 1: Maximum Observed Plasma Concentration (Cmax) | Up to 11 weeks |
| Part 1: Time to Reach Cmax (Tmax) | Up to 11 weeks |
| Part 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | Up to 11 weeks |
| Part 1 & Part 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 11 weeks |
| Part 1 & Part 2: Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR | Up to 11 weeks |
| Part 1 & Part 2: Absolute Values for 12-lead ECGs Recording of Intervals | Intervals recorded: - PR. - QRS. - QT. - QTc | Up to 11 weeks |
| Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of HR | The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value. | Baseline and up to 11 weeks |
| Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals | The 3 predose measures will be recorded and will be averaged for QTc interval to derive 1 baseline value. Intervals recorded: - PR. - QRS. - QT. - QTc | Up to 11 weeks |
| Part 1 & Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters | Up to 11 weeks |
| Part 1 & Part 2: Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure) | Up to 11 weeks |
| Part 1 & Part 2: Absolute Values of Vital Signs (Pulse Rate) | Up to 11 weeks |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided