A study to assess bronchospasm potentially induced by HFO MDI as compared with HFA MDI in participants with well controlled or partially controlled asthma
This is a phase 3b, multicentre, randomized, double-blind, single-dose crossover study comparing the safety and tolerability of HFO MDI with HFA MDI delivered in participants with well controlled or partially controlled asthma defined as an ACQ-5 score \< 1.5.Eligible participants are at least 18 years of age and no older than 45 years of age and are required to have asthma as defined by GINA guidelines (GINA 2022). Participants are required to be well controlled or partially controlled on their current treatment for asthma, including, low-dose ICS daily or low-dose ICS/formoterol as needed (not approved in the US), or SABA as needed, or low-dose ICS whenever SABA as needed is used. The primary objective is to assess the potential change in FEV1 induced by HFO MDI as compared with HFA MDI in participants with asthma. This study will be conducted at approximately 5 sites in the US and will randomize approximately 52 adult participants to achieve 46 completers. The study will be conducted for a maximal 37 days and will comprise: * A screening period approximately 14 (±2) days prior to first dosing * Two treatment periods of 1 day each, with a 3 to 12-day washout period between the 2 treatment periods * A final safety follow-up visit via telephone contact 3 to 7 days after the final dose administration in Treatment Period 2 Single dose study treatment will be administered via MDI device as 4 inhalations: * Treatment A: HFO propellant only MDI; 4 inhalations per dose - test formulation * Treatment B: HFA propellant only MDI; 4 inhalations per dose - reference formulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
* Dose formulation: MDI * Unit dose strength(s): Reference (propellant only) * Dosage Level: 4 inhalations, single dose * Route of administration: Oral inhalation * Participants will receive treatment A in 1 or 2 possible sequences AB or BA
* Dose formulation: MDI * Unit dose strength(s): Experimental (propellant only) * Dosage Level: 4 inhalations, single dose * Route of administration: Oral inhalation * Participants will receive treatment A in 1 or 2 possible sequences AB or BA
Research Site
North Dartmouth, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Raleigh, North Carolina, United States
Research Site
El Paso, Texas, United States
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 15 Minutes (AUC0-15 Min) Post-dose
The change from baseline (30 minutes pre-dose) in normalized FEV1 AUC0-15 min postdose induced by Treatment HFO was compared with Treatment HFA.
Time frame: 30 minutes prior to dosing and at 5, 15, and 30 minutes post-dose
Number of Participants With Bronchospasm Events
The potential of Treatment HFO to induce bronchospasm was compared with Treatment HFA. The number of participants with bronchospasm events post-dose (5 or 15 minutes post-dose) from baseline (30 minutes pre-dose) for each treatment is presented. An event of bronchospasm is defined as a reduction in FEV1 of \>15% from baseline (i.e. the FEV1 value obtained within 30 minutes prior to study intervention administration) at 5 or 15 minutes post-dose, with associated symptoms of wheezing, shortness of breath, or cough.
Time frame: 30 minutes prior to dosing and at 5 and 15 minutes post-dose
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
The number of AEs, SAEs, and AESIs for Treatment HFO and Treatment HFA are presented.
Time frame: From screening (Day - 14) to the last dose (day 8) + 7 days
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