Study to assess bronchospasm potentially induced by HFO vs HFA MDI in participants with well/partially controlled asthma

Inclusion Criteria

• - Age
• 1 Male and female participant must be 18 to 45 years of age inclusive, at the time of
• signing the informed consent form (ICF).
• Type of Participant and Disease Characteristics
• 2 Participants who have a documented history of physician-diagnosed asthma
• ≥ 12 months prior to Visit 1, according to GINA guidelines (GINA 2022).
• 3 Participants who are 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 (low-dose ICS as defined by GINA 2022 in Table 4), for 4 weeks prior to
• screening.
• 4 ACQ-5 total score < 1.5 at Visit 1.
• 5 A pre-bronchodilator FEV1 > 60% predicted normal value at Visit 1.
• 6 Demonstrate acceptable MDI administration technique.
• Sex and Contraceptive/Barrier Requirements
• 7 Females must be not of childbearing potential, or should be using a form of highly
• effective birth control as defined below:
• -Female participants Women not of childbearing potential are defined as women
• who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or
• bilateral salpingectomy), or who are postmenopausal. Women included in this
• study will be considered postmenopausal if they have been amenorrhoeic for
• 12 months or more following cessation of exogenous hormonal treatment and
• follicle-stimulating hormone levels in the postmenopausal range.
• -Female participants of childbearing potential must use one highly effective form
• of birth control. A highly effective method of contraception is defined as one that
• can achieve a failure rate of less than 1% per year when used consistently and
• correctly. At enrolment, women of childbearing potential who are sexually active
• with a non-sterilized male partner should be stable on their chosen method of
• highly effective birth control, as defined below, and willing to remain on the birth
• control until at least 14 days after last dose of study intervention. Cessation of
• contraception after this point should be discussed with a responsible physician.
• Periodic abstinence (calendar, symptothermal, post-ovulation methods),
• withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea
• method are not acceptable methods of contraception. Female condom and male
• condom should not be used together. All women of childbearing potential must
• have a negative serum pregnancy test result at Visit 1.
• -Highly effective birth control methods are listed below:
• -Total sexual abstinence is an acceptable method provided it is the usual
• lifestyle of the participant (defined as refraining from heterosexual
• intercourse during the entire period of risk associated with the study
• treatments). Periodic abstinence (e.g., calendar, ovulation, symptothermal,
• post-ovulation methods), declaration of abstinence for the duration of
• exposure to study intervention, and withdrawal are not acceptable methods
• of contraception.
• -Contraceptive subdermal implant
• -Intrauterine device or intrauterine system
• -Oral contraceptive (combined or progesterone only)
• -Injectable progestogen
• -Contraceptive vaginal ring
• -Percutaneous contraceptive patches
• -Male partner sterilization with documentation of azoospermia prior to the
• female participant’s entry into the study, and this male is the sole partner for
• that participant. The documentation on male sterility can come from the site personnel’s review of participant’s medical records, medical examination
• and/or semen analysis or medical history interview provided by her or her
• partner.
• -Bilateral tubal ligation
• Informed Consent
• 8 Capable of giving signed informed consent as described in Appendix A which includes
• compliance with the requirements and restrictions listed in the ICF and in this protocol.