A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test)… (NCT06702462) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma
United States20 participantsStarted 2025-03-11
Plain-language summary
The purpose of the study is to assess the propellants,1 - Difluoroethane \[HFA-152a\] (Test) and 1,1,1,2-Tetrafluoroethane \[HFA-134a\] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
Participants are eligible to be included in the study if all the following criteria apply:
* Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
* Participant must be 18 to 45 years of age inclusive, at the time of screening.
* Confirmed diagnosis of asthma: documented, established diagnosis of asthma for at least 6 months.
* Receiving 1 of the 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:
* As needed short-acting beta-agonists (SABA) only
* As needed SABA plus low-dose Inhaled corticosteroids (ICS) (defined as 100-250 µg/day fluticasone propionate or equivalent taken whenever SABA is taken).
* Daily maintenance low-dose ICS, plus as needed SABA or ICS-SABA single inhaler combination therapy
* Low dose combination single inhaler ICS-formoterol or single inhaler ICS-SABA as needed for symptom relief (and if needed, before exercise)
* Leukotriene receptor antagonist (LTRAs) in combination with any of the above therapies
* Asthma Control Questionnaire (ACQ)-6 score \<1.5 at screening and Day -1.
* No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
* Lung function: subjects with a pre-bronchodilator FEV1 ≥60% predicted at Screening and Day-1.
* A female participant is eligible to participate if …
What they're measuring
1
Percentage change from baseline in Forced expiratory volume in 1 second (FEV1) at 15 minutes
Timeframe: Baseline (0 minutes) and at 15 minutes post dose