Study to investigate changes in airway inflammation, symptoms, and rescue therapy utilization with AIRSUPRA compared to albuterol as needed in adults with mild asthma - DARWIN

Inclusion Criteria

• Informed Consent
• 1 Capable of giving signed informed consent as described in the protocol which included compliance with the requirements and restrictions listed in the ICF and protocol
• Type of Participant and Disease Characteristics
• 3 Diagnosis of asthma, by a prescribing health care professional
• 4 ≥ 2 prescriptions for a SABA inhaler in the past 12 months prior to Visit 1 (and the expectation that the participant will probably use their rescue inhaler ≥ 2 days per week as this is required at Visit 2 for randomization following the Lead-in Period)
• 5 FeNO ≥ 25 ppb at Visit 1
• Sex and Contraceptive/Barrier Requirements
• 7 Female participants: Females must be not of childbearing potential or using a form of birth control as defined below:
• • Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. The following age-specific requirements apply:
• o Females < 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.
• o Females ≥ 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
• • Female participants of childbearing potential must use a 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. Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and 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 amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
• o All females of childbearing potential must have a negative pregnancy test result at Visit 1.
• o Females < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.
• • Highly effective birth control methods are listed below:
• o 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).
• o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• • Oral
• • Intravaginal
• • Transdermal
• o Progestogen-only hormonal contraception associated with inhibition of ovulation:
• • Oral
• •Injectable
• • Implantable
• o Intrauterine device or intrauterine hormone-releasing system
• o Bilateral tubal occlusion
• o Male partner sterilization/vasectomy 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.
• 8 Negative pregnancy test (urine) for female participants of childbearing potential at Visit 1.
• Randomization Criteria 5.1.1 at Visit 2 (Week 0)
• 1 Symptoms requiring rescue medication use for a minimum of 2 days per week for the last 14 days during the Lead-in Period (minimum 4 uses total)
• 2 At least 80% overall compliance rate for performing daily FeNO and spirometry assessments and completing the twice-daily asthma symptom and rescue medication use diary during the Lead-in Period.