Study to Assess Bronchospasm Potentially Induced by HFO vs HFA MDI in Participants With Well/Partially Controlled Asthma
Condition: Asthma
MeSH terms: Asthma; Bronchial Spasm
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess bronchospasm potentially induced by HFO MDI as compared with HFA MDI in
      participants with well controlled or partially controlled asthma
    

Detailed description: 
      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
    

Intervention name(s): HFA MDI; HFO MDI
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Propellant in MDI; Propellant in MDI
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The purpose of this study is to assess bronchospasm potentially induced by hydrofluoroolefin (HFO) metered dose inhaler (MDI) as compared with hydrofluoroalkane (HFA) MDI in participants with asthma, well controlled or partially controlled on treatment for asthma, including, low-dose inhaled corticosteroid (ICS) daily or low-dose ICS/formoterol as needed (not approved in the US), or short-acting beta2-agonists (SABA) as needed, or low-dose ICS whenever SABA as needed is used.
Study details include:
The study duration will be up to 37 days.
The treatment duration will be 1 day for each treatment period.
The visit frequency will be approximately every 1 week.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, Bronchospasm