A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive

Last updated: May 8, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1

Condition

Asthma

Treatment

Salbutamol HFA-134a

Salbutamol HFA-152a

Placebo

Clinical Study ID

NCT06433921
219729
2024-511220-14
2024-511220-14-00
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female; females may be of childbearing potential, of nonchildbearingpotential, or postmenopausal.

  2. Participant must be 18 to 65 years of age inclusive, at the time of screening.

  3. ≥50 kg, at the time of screening.

  4. Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.

  5. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthmatreatments, at a stable dose, for at least 12 weeks prior to the screening visit andis anticipated to remain stable for the duration of the study: i. Short-actingbeta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minusSABA 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.

  1. No severe asthma exacerbations within 6 months prior to screening and ≤1 severeexacerbation during the 12 months prior to screening.

  2. 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 ≥8 hoursand LABA-containing medications for ≥48 hours for the purposes of performing thespirometry and methacholine challenge at screening and during the study visits (treatment periods).

  3. A female participant is eligible to participate if she is not pregnant orbreastfeeding, 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 thatis highly effective.

  4. Provide signed informed consent which includes compliance with the requirements andrestrictions listed in the informed consent form and in this protocol.

  5. Non-smokers who have not used any tobacco containing-products within 12 months priorto study start, and with a total pack year history of ≤10 pack years.

Exclusion

Exclusion Criteria:

  1. Medical Conditions

  2. A history of life-threatening asthma or asthma that is unstable in the opinionof the investigator.

  3. A history of respiratory diseases to include (but not limited to):pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronicbronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease,emphysema, chronic obstructive pulmonary disease, tuberculosis, or otherrespiratory abnormalities other than asthma.

  4. Asymptomatic gallstones.

  5. History or current evidence of hematologic, neurologic, psychiatric, or otherdiseases that, in the opinion of the investigator, would put the participant atrisk through study participation, or would affect the study analyses if thedisease exacerbates during the study.

  6. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.

  7. Current use of cholinesterase inhibitor medication e.g., to treat myastheniagravis.

  8. Exposure to more than 4 new chemical entities within 12 months prior to the firstdosing day or participation in a clinical study within 30 days of study start, or 5half-lives of study drug if that is longer.

  9. Participants who are currently or in the last 15 days have worked nightshifts.

  10. Regular alcohol consumption within 6 months prior to the study defined as: anaverage weekly intake of >21 units for males or >14 units for females.

  11. A positive test result for drugs of abuse (including tetrahydrocannabinol) atscreening or Day -1.

  12. Use of combustible tobacco products, and non-combustible nicotine delivery systems,inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12months prior to the start of the study.

Study Design

Total Participants: 91
Treatment Group(s): 3
Primary Treatment: Salbutamol HFA-134a
Phase: 1
Study Start date:
August 14, 2024
Estimated Completion Date:
August 14, 2026

Connect with a study center

  • GSK Investigational Site

    Sofia, 1612
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Hannover, 30625
    Germany

    Site Not Available

  • GSK Investigational Site

    Jozefow, 05-410
    Poland

    Site Not Available

  • GSK Investigational Site

    Bucuresti, 012292
    Romania

    Site Not Available

  • GSK Investigational Site

    Belfast, BT9 6AD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cardiff, CF48 4 DR
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, NE10 7EW
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Manchester, M23 9QZ
    United Kingdom

    Active - Recruiting

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