ACTIVE_NOT_RECRUITING

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 Respiratory Hypersensitivity Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A 12-week, Randomized, Double-Blind, Phase 4 Study Evaluating the Effect of AIRSUPRA Compared to Albuterol Administered as Needed on Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization in Adults With Mild Asthma

Quick Facts

Study Start:2024-09-11

Study Completion:2026-02-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06563102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: * 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. * 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. * All females of childbearing potential must have a negative pregnancy test result at Visit 1. * 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: * 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). * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * Oral * Intravaginal * Transdermal * Progestogen-only hormonal contraception associated with inhibition of ovulation: * Oral * Injectable * Implantable * Intrauterine device or intrauterine hormone-releasing system * Bilateral tubal occlusion * 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. 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.	1. Any significant disease or disorder, or evidence of drug/substance abuse which in the investigator's opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study. 2. Medical history of life-threatening asthma including intubation and intensive care unit admission. 3. Medical conditions (other than allergic rhinitis) or medications that will influence FeNO, as judged by the investigator. 4. Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary disease). 5. Any disease state or procedure that is likely to necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma. 6. Malignancy: a current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (participants with treated localized squamous cell or basal cell carcinoma of the skin will not be excluded, whereas participants who had melanoma will be excluded). Participants with a history/treatment of malignancy, and which in the investigator's opinion could compromise the safety of the participant. 7. Other concurrent medical conditions: participants who have known, pre-existing, clinically significant cardiovascular (including clinically significant cardiac arrhythmia and participants with known QT interval corrected for heart rate using the Fridericia formula \> 480 ms), endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment. 8. Current smokers: previous smokers are allowed to be included provided that they stopped smoking \> 12 months prior to Visit 1 AND have a smoking history of ≤ 10 pack-years (includes tobacco, e-cigarettes, vapes, marijuana, etc.). 9. Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1. 10. Use of ICS-containing therapy for maintenance or rescue at enrolment. Other therapies for maintenance of asthma control are allowed (leukotriene receptor antagonists 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) 13. Participation in another clinical study with any marketed or investigational anti-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 product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1. 15. Participants with a known hypersensitivity to the study drugs or any of the excipients of the products. 16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff 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 objectives as judged by the investigator.

Inclusion Criteria

Exclusion Criteria

* 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:
* 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.
* 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.
* All females of childbearing potential must have a negative pregnancy test result at Visit 1.
* 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:
* 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).
* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
* Oral
* Intravaginal
* Transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation:
* Oral
* Injectable
* Implantable
* Intrauterine device or intrauterine hormone-releasing system
* Bilateral tubal occlusion
* 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.
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.

1. Any significant disease or disorder, or evidence of drug/substance abuse which in the investigator's opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study.
2. Medical history of life-threatening asthma including intubation and intensive care unit admission.
3. Medical conditions (other than allergic rhinitis) or medications that will influence FeNO, as judged by the investigator.
4. Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary disease).
5. Any disease state or procedure that is likely to necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma.
6. Malignancy: a current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (participants with treated localized squamous cell or basal cell carcinoma of the skin will not be excluded, whereas participants who had melanoma will be excluded). Participants with a history/treatment of malignancy, and which in the investigator's opinion could compromise the safety of the participant.
7. Other concurrent medical conditions: participants who have known, pre-existing, clinically significant cardiovascular (including clinically significant cardiac arrhythmia and participants with known QT interval corrected for heart rate using the Fridericia formula \> 480 ms), endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
8. Current smokers: previous smokers are allowed to be included provided that they stopped smoking \> 12 months prior to Visit 1 AND have a smoking history of ≤ 10 pack-years (includes tobacco, e-cigarettes, vapes, marijuana, etc.).
9. Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
10. Use of ICS-containing therapy for maintenance or rescue at enrolment. Other therapies for maintenance of asthma control are allowed (leukotriene receptor antagonists 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)
13. Participation in another clinical study with any marketed or investigational anti-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 product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1.
15. Participants with a known hypersensitivity to the study drugs or any of the excipients of the products.
16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff 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 objectives as judged by the investigator.

Contacts and Locations

Study Locations (Sites)

Research Site

Phoenix, Arizona, 85040

United States

Research Site

Tucson, Arizona, 85715

United States

Research Site

Lancaster, California, 93534

United States

Research Site

San Diego, California, 92123

United States

Research Site

Cape Coral, Florida, 33990

United States

Research Site

Lake Worth, Florida, 33462

United States

Research Site

Columbus, Georgia, 31904

United States

Research Site

Boise, Idaho, 83706

United States

Research Site

Plainfield, Indiana, 46168

United States

Research Site

St Louis, Missouri, 63141

United States

Research Site

Riverdale, New Jersey, 07457

United States

Research Site

Oklahoma City, Oklahoma, 73120

United States

Research Site

North Charleston, South Carolina, 29420

United States

Research Site

El Paso, Texas, 79903

United States

Research Site

Houston, Texas, 77030

United States

Research Site

Waco, Texas, 76712

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11

Study Completion Date2026-02-20

Study Record Updates

Study Start Date2024-09-11

Study Completion Date2026-02-20

Terms related to this study

Keywords Provided by Researchers

Respiratory Hypersensitivity
Asthma

Additional Relevant MeSH Terms

Mild Asthma