Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
- Conditions
- Mild Asthma
- Registration Number
- NCT06563102
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br>Informed Consent<br><br>1 Capable of giving signed informed consent as described in the protocol which included<br>compliance with the requirements and restrictions listed in the ICF and protocol<br><br>Type of Participant and Disease Characteristics 3 Diagnosis of asthma, by a prescribing<br>health care professional 4 = 2 prescriptions for a SABA inhaler in the past 12 months<br>prior to Visit 1 (and the expectation that the participant will probably use their rescue<br>inhaler = 2 days per week as this is required at Visit 2 for randomization following the<br>Lead-in Period) 5 FeNO = 25 ppb at Visit 1<br><br>Sex and Contraceptive/Barrier Requirements 7 Female participants: Females must be not of<br>childbearing potential or using a form of birth control as defined below:<br><br> - Females not of childbearing potential are defined as females who are either<br> permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral<br> salpingectomy), or who are postmenopausal. The following age-specific requirements<br> apply:<br><br> - Females < 50 years old would be considered postmenopausal if they have been<br> amenorrheic for 12 months or more following cessation of exogenous hormonal<br> treatment and in the absence of any alternative medical cause, as judged by the<br> investigator.<br><br> - Females = 50 years old would be considered postmenopausal if they have been<br> amenorrheic for 12 months or more following cessation of all exogenous hormonal<br> treatment.<br><br> - Female participants of childbearing potential must use a highly effective form of<br> birth control. A highly effective method of contraception is defined as one that can<br> achieve a failure rate of less than 1% per year when used consistently and<br> correctly. Females of childbearing potential who are sexually active with a<br> non-sterilized male partner must agree to use one highly effective method of birth<br> control, as defined below, from enrolment throughout the study and until at least 14<br> days after last dose of study intervention. Cessation of contraception after this<br> point should be discussed with a responsible physician. Periodic abstinence<br> (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus),<br> spermicides only, and lactational amenorrhea method are not acceptable methods of<br> contraception. Female condom and male condom should not be used together.<br><br> - All females of childbearing potential must have a negative pregnancy test<br> result at Visit 1.<br><br> - Females < 50 years old would be considered postmenopausal if they have been<br> amenorrhoeic for 12 months or more following cessation of exogenous hormonal<br> treatment and in the absence of any alternative medical cause, as judged by the<br> investigator.<br><br> - Highly effective birth control methods are listed below:<br><br> - Total sexual abstinence is an acceptable method provided it is the usual<br> lifestyle of the participant (defined as refraining from heterosexual<br> intercourse during the entire period of risk associated with the study<br> treatments).<br><br> - Combined (estrogen and progestogen containing) hormonal contraception<br> associated with inhibition of ovulation:<br><br> - Oral<br><br> - Intravaginal<br><br> - Transdermal<br><br> - Progestogen-only hormonal contraception associated with inhibition of<br> ovulation:<br><br> - Oral<br><br> - Injectable<br><br> - Implantable<br><br> - Intrauterine device or intrauterine hormone-releasing system<br><br> - Bilateral tubal occlusion<br><br> - Male partner sterilization/vasectomy with documentation of azoospermia prior to<br> the female participant's entry into the study, and this male is the sole<br> partner for that participant. The documentation on male sterility can come from<br> the site personnel's review of participant's medical records, medical<br> examination and/or semen analysis or medical history interview provided by her<br> or her partner.<br><br> 8 Negative pregnancy test (urine) for female participants of childbearing<br> potential at Visit 1.<br><br>Randomization Criteria 5.1.1 at Visit 2 (Week 0)<br><br> 1. Symptoms requiring rescue medication use for a minimum of 2 days per week for the<br> last 14 days during the Lead-in Period (minimum 4 uses total)<br><br> 2. At least 80% overall compliance rate for performing daily FeNO and spirometry<br> assessments and completing the twice-daily asthma symptom and rescue medication use<br> diary during the Lead-in Period.<br><br>Exclusion Criteria:<br><br>Medical Conditions<br><br> 1. Any significant disease or disorder, or evidence of drug/substance abuse which in<br> the investigator's opinion would pose a risk to participant safety, interfere with<br> the conduct of study, have an impact on the study results, or make it undesirable<br> for the participant to participate in the study.<br><br> 2. Medical history of life-threatening asthma including intubation and intensive care<br> unit admission.<br><br> 3. Medical conditions (other than allergic rhinitis) or medications that will influence<br> FeNO, as judged by the investigator.<br><br> 4. Concurrent respiratory disease: presence of a known pre-existing, clinically<br> important lung condition other than asthma (eg, cystic fibrosis, idiopathic<br> pulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary<br> disease).<br><br> 5. Any disease state or procedure that is likely to necessitate the use of<br> oral/systemic corticosteroids during the Treatment Period, other than asthma.<br><br> 6. Malignancy: a current malignancy or previous history of cancer in remission for less<br> than 12 months prior to Visit 1 (participants with treated localized squamous cell<br> or basal cell carcinoma of the skin will not be excluded, whereas participants who<br> had melanoma will be excluded). Participants with a history/treatment of malignancy,<br> and which in the investigator's opinion could compromise the safety of the<br> participant.<br><br> 7. Other concurrent medical conditions: participants who have known, pre-existing,<br> clinically significant cardiovascular (including clinically significant cardiac<br> arrhythmia and participants with known QT interval corrected for heart rate using<br> the Fridericia formula > 480 ms), endocrine, autoimmune, metabolic, neurological,<br> renal, gastrointestinal, hepatic, haematological or any other system abnormalities<br> that are uncontrolled with standard treatment.<br><br> 8. Current smokers: previous smokers are allowed to be included provided that they<br> stopped smoking > 12 months prior to Visit 1 AND have a smoking history of = 10<br> pack-years (includes tobacco, e-cigarettes, vapes, marijuana, etc.).<br><br> 9. Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or<br> substance abuse within 2 years prior to Visit 1.<br><br> Prior/Concomitant Therapy<br><br> 10. Use of ICS-containing therapy for maintenance or rescue at enrolment. Other<br> therapies for maintenance of asthma control are allowed (leukotriene receptor<br> antagonists and/or antihistamines, for example), but not LAMA or LABA.<br><br> 11. Use of any systemic or inhaled corticosteroid within 4 weeks of Visit 1<br><br> 12. Planned use of a nebulizer during the study (between Visits 1 and 5)<br
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to maximum value of daily morning FeNO
- Secondary Outcome Measures
Name Time Method Change from baseline in FeNO on high inflammation days;Number of days with high inflammation (annualized rate);Number of days with daily morning FeNO measurements = 50 ppb (annualized rate);Number of days with daily morning FeNO measurements = 25 ppb (annualized rate);Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment