ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT06433921.
- What is being tested: The study compares the effectiveness and potency of salbutamol (albuterol) delivered via metered dose inhalers using two different propellant systems—HFA-152a (newer) versus HFA-134a (established)—by measuring airway responsiveness using methacholine challenge testing in mild asthmatic patients.
- Patient eligibility: The trial includes adults aged 18-65 years with mild asthma, establishing a defined population for evaluating propellant formulation differences in a clinically relevant but controlled patient group.
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What This Trial Is Studying
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 Snapshot
- : 1. 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. 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. 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.