Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma

Last updated: April 14, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

4

Condition

Asthma

Inflammation

Treatment

Albuterol

Albuterol/Budesonide

Clinical Study ID

NCT06563102
D6930C00018
  • Ages 18-120
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.

Study details include:

  • The study duration will be up to 15 weeks.

  • The treatment duration will be 12 weeks.

  • The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.

Eligibility Criteria

Inclusion

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 eitherpermanently sterilized (hysterectomy, bilateral oophorectomy, or bilateralsalpingectomy), or who are postmenopausal. The following age-specific requirementsapply:

  • Females < 50 years old would be considered postmenopausal if they have beenamenorrheic for 12 months or more following cessation of exogenous hormonaltreatment and in the absence of any alternative medical cause, as judged by theinvestigator.

  • Females ≥ 50 years old would be considered postmenopausal if they have beenamenorrheic for 12 months or more following cessation of all exogenous hormonaltreatment.

  • Female participants of childbearing potential must use a highly effective form ofbirth control. A highly effective method of contraception is defined as one that canachieve a failure rate of less than 1% per year when used consistently andcorrectly. Females of childbearing potential who are sexually active with anon-sterilized male partner must agree to use one highly effective method of birthcontrol, as defined below, from enrolment throughout the study and until at least 14days after last dose of study intervention. Cessation of contraception after thispoint 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 ofcontraception. Female condom and male condom should not be used together.

  • All females of childbearing potential must have a negative pregnancy testresult at Visit 1.

  • Females < 50 years old would be considered postmenopausal if they have beenamenorrhoeic for 12 months or more following cessation of exogenous hormonaltreatment and in the absence of any alternative medical cause, as judged by theinvestigator.

  • Highly effective birth control methods are listed below:

  • Total sexual abstinence is an acceptable method provided it is the usuallifestyle of the participant (defined as refraining from heterosexualintercourse during the entire period of risk associated with the studytreatments).

  • Combined (estrogen and progestogen containing) hormonal contraceptionassociated with inhibition of ovulation:

  • Oral

  • Intravaginal

  • Transdermal

  • Progestogen-only hormonal contraception associated with inhibition ofovulation:

  • Oral

  • Injectable

  • Implantable

  • Intrauterine device or intrauterine hormone-releasing system

  • Bilateral tubal occlusion

  • Male partner sterilization/vasectomy with documentation of azoospermia prior tothe female participant's entry into the study, and this male is the solepartner for that participant. The documentation on male sterility can come fromthe site personnel's review of participant's medical records, medicalexamination and/or semen analysis or medical history interview provided by heror her partner. 8 Negative pregnancy test (urine) for female participants of childbearingpotential 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 thelast 14 days during the Lead-in Period (minimum 4 uses total)

  2. At least 80% overall compliance rate for performing daily FeNO and spirometryassessments and completing the twice-daily asthma symptom and rescue medication usediary during the Lead-in Period.

Exclusion

Exclusion Criteria:

Medical Conditions

  1. Any significant disease or disorder, or evidence of drug/substance abuse which inthe investigator's opinion would pose a risk to participant safety, interfere withthe conduct of study, have an impact on the study results, or make it undesirablefor the participant to participate in the study.

  2. Medical history of life-threatening asthma including intubation and intensive careunit admission.

  3. Medical conditions (other than allergic rhinitis) or medications that will influenceFeNO, as judged by the investigator.

  4. Concurrent respiratory disease: presence of a known pre-existing, clinicallyimportant lung condition other than asthma (eg, cystic fibrosis, idiopathicpulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonarydisease).

  5. Any disease state or procedure that is likely to necessitate the use oforal/systemic corticosteroids during the Treatment Period, other than asthma.

  6. Malignancy: a current malignancy or previous history of cancer in remission for lessthan 12 months prior to Visit 1 (participants with treated localized squamous cellor basal cell carcinoma of the skin will not be excluded, whereas participants whohad melanoma will be excluded). Participants with a history/treatment of malignancy,and which in the investigator's opinion could compromise the safety of theparticipant.

  7. Other concurrent medical conditions: participants who have known, pre-existing,clinically significant cardiovascular (including clinically significant cardiacarrhythmia and participants with known QT interval corrected for heart rate usingthe Fridericia formula > 480 ms), endocrine, autoimmune, metabolic, neurological,renal, gastrointestinal, hepatic, haematological or any other system abnormalitiesthat are uncontrolled with standard treatment.

  8. Current smokers: previous smokers are allowed to be included provided that theystopped smoking > 12 months prior to Visit 1 AND have a smoking history of ≤ 10pack-years (includes tobacco, e-cigarettes, vapes, marijuana, etc.).

  9. Alcohol/substance abuse: a history (or suspected history) of alcohol misuse orsubstance abuse within 2 years prior to Visit 1. Prior/Concomitant Therapy

  10. Use of ICS-containing therapy for maintenance or rescue at enrolment. Othertherapies for maintenance of asthma control are allowed (leukotriene receptorantagonists and/or antihistamines, for example), but not LAMA or LABA.

  11. Use of any systemic or inhaled corticosteroid within 4 weeks of Visit 1

  12. Planned use of a nebulizer during the study (between Visits 1 and 5) Prior/Concurrent Clinical Study Experience

  13. Participation in another clinical study with any marketed or investigationalanti-allergic or immunosuppressant biologic drug within 4 months or 5 half-lives (whichever is longer) prior to Visit 1.

  14. Participation in another clinical study with a non-biologic investigational productor new formulation of a marketed non-biologic drug during the last 30 days prior toVisit 1. Other Exclusions

  15. Participants with a known hypersensitivity to the study drugs or any of theexcipients of the products.

  16. Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).

  17. Previous randomization in the present study.

  18. For women only: currently pregnant (confirmed with positive pregnancy test),breastfeeding or planned pregnancy during the study.

  19. Planned hospitalization during the study that would interfere with study objectivesas judged by the investigator.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Albuterol
Phase: 4
Study Start date:
September 11, 2024
Estimated Completion Date:
November 10, 2025

Study Description

DARWIN is a randomized, active-comparator, double-blind, parallel-group, Phase IV study evaluating the effect of albuterol/budesonide (AIRSUPRA) compared to albuterol administered as-needed in response to symptoms on changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.

Approximately 15 sites in the United States of America will enroll adult participants with mild asthma who use albuterol as a rescue inhaler and who do not take ICS as maintenance therapy.

The study will be divided in 2 periods (Lead-in Period and Treatment Period) and the total duration of the study for each participant could be up to 15 weeks, with a visit frequency of once every 4 weeks:

  • Lead-In Period: Up to 3 weeks

  • Treatment Period: 12 weeks

Connect with a study center

  • Research Site

    Phoenix, Arizona 85040
    United States

    Active - Recruiting

  • Research Site

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Research Site

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Research Site

    San Diego, California 92123
    United States

    Active - Recruiting

  • Research Site

    Cape Coral, Florida 33990
    United States

    Active - Recruiting

  • Research Site

    Lake Worth, Florida 33462
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33613
    United States

    Site Not Available

  • Research Site

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Research Site

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Research Site

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Research Site

    Riverdale, New Jersey 07457
    United States

    Active - Recruiting

  • Research Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Research Site

    Pottstown, Pennsylvania 19464
    United States

    Active - Recruiting

  • Research Site

    North Charleston, South Carolina 29420
    United States

    Active - Recruiting

  • Research Site

    El Paso, Texas 79903
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Waco, Texas 76712
    United States

    Active - Recruiting

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