Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma

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.

What this study is about