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NCT Number: NCT06433921

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
  • Participant must be 18 to 65 years of age inclusive, at the time of screening.
  • ≥50 kg, at the time of screening.
  • Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.
  • 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.

  • No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
  • 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).
  • 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.
  • Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
  • 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
  • A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
  • A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.
  • Asymptomatic gallstones.
  • History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
  • Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.
  • Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)

    Time frame: Up to 11 weeks

Secondary outcomes

  1. Part 1 & Part 2: Peak QTc Interval

    Time frame: Up to 11 weeks

  2. Part 1 & Part 2: Peak Heart Rate (HR)

    Time frame: Up to 11 weeks

  3. Part 1 & Part 2: Minimum Serum Potassium

    Time frame: Up to 11 weeks

  4. Part 1: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 11 weeks

  5. Part 1: Time to Reach Cmax (Tmax)

    Time frame: Up to 11 weeks

  6. 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])

    Time frame: Up to 11 weeks

  7. Part 1 & Part 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 11 weeks

  8. Part 1 & Part 2: Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR

    Time frame: Up to 11 weeks

  9. Part 1 & Part 2: Absolute Values for 12-lead ECGs Recording of Intervals

    Time frame: Up to 11 weeks

    Intervals recorded: - PR. - QRS. - QT. - QTc

  10. Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of HR

    Time frame: Baseline and up to 11 weeks

    The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value.

  11. Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals

    Time frame: Up to 11 weeks

    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

  12. Part 1 & Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters

    Time frame: Up to 11 weeks

  13. Part 1 & Part 2: Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure)

    Time frame: Up to 11 weeks

  14. Part 1 & Part 2: Absolute Values of Vital Signs (Pulse Rate)

    Time frame: Up to 11 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 30, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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