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

NCT06563102 | Completed Phase 4 FDA Drug

• 1 other identifier: D6930C00018
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Mild Asthma

Keywords

Respiratory Hypersensitivity; Asthma

Outcome Measures

Primary Outcomes (1)

• Change from baseline to maximum value of daily morning FeNO

  Change from baseline to maximum value of daily morning FeNO over 12 weeks of treatment in the albuterol/budesonide group compared to the albuterol group.

  Daily over 12 weeks

Secondary Outcomes (5)

• Change from baseline in FeNO on high inflammation days

  Daily over 12 weeks

• Number of days with high inflammation (annualized rate)

  Daily over 12 weeks

• Number of days with daily morning FeNO measurements ≥ 50 ppb (annualized rate)

  Daily over 12 weeks

• Number of days with daily morning FeNO measurements ≥ 25 ppb (annualized rate)

  Daily over 12 weeks

• Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment

  Daily over 12 weeks

Other Outcomes (1)

• Number of SAEs and DAEs

  Week 12

Study Arms (2)

Group 1 - Participants randomized to receive albuterol/budesonide

EXPERIMENTAL

Participants will be randomized based on Visit 1 FeNO levels (\< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.

Combination Product: Albuterol/Budesonide

Group 2 - Participants randomized to receive albuterol

ACTIVE COMPARATOR

Participants will be randomized based on Visit 1 FeNO levels (\< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.

Combination Product: Albuterol

Interventions

Albuterol/Budesonide COMBINATION_PRODUCT

Oral Inhalation. Rescue medication. Unit dose strength of 80 μg budesonide and 90 μg albuterol per actuation

Also known as: AIRSUPRA, BDA MDI HFA

Group 1 - Participants randomized to receive albuterol/budesonide

Albuterol COMBINATION_PRODUCT

Oral Inhalation. Rescue medication. Unit dose strength of 90μg albuterol per actuation.

Also known as: AS MDI

Group 2 - Participants randomized to receive albuterol

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent
• 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:
• 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

You may not qualify if:

• Medical Conditions
• 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.
• Medical history of life-threatening asthma including intubation and intensive care unit admission.
• Medical conditions (other than allergic rhinitis) or medications that will influence FeNO, as judged by the investigator.
• 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).
• Any disease state or procedure that is likely to necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma.
• 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.
• 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.
• 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.).
• Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
• Prior/Concomitant Therapy
• 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.
• Use of any systemic or inhaled corticosteroid within 4 weeks of Visit 1
• Planned use of a nebulizer during the study (between Visits 1 and 5)
• Prior/Concurrent Clinical Study Experience

Sponsors & Collaborators

• AstraZeneca: lead
• Fortrea: collaborator

Study Sites (16)

Research Site

Phoenix, Arizona, 85040, United States

Location

Research Site

Tucson, Arizona, 85715, United States

Location

Research Site

Lancaster, California, 93534, United States

Location

Research Site

San Diego, California, 92123, United States

Location

Research Site

Cape Coral, Florida, 33990, United States

Location

Research Site

Lake Worth, Florida, 33462, United States

Location

Research Site

Columbus, Georgia, 31904, United States

Location

Research Site

Boise, Idaho, 83706, United States

Location

Research Site

Plainfield, Indiana, 46168, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Riverdale, New Jersey, 07457, United States

Location

Research Site

Oklahoma City, Oklahoma, 73120, United States

Location

Research Site

North Charleston, South Carolina, 29420, United States

Location

Research Site

El Paso, Texas, 79903, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Respiratory Hypersensitivity; Asthma

Interventions

Albuterol; Budesonide

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both albuterol/budesonide and albuterol will be supplied in identical inhalers and the maximum daily dose is the same for the 2 IMPs (6 doses, ie, 12 inhalations/day).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At Visit 2 (Week 0), participants who demonstrated ≥ 80% compliance with all at-home study procedures during the last 14 days of the Lead-in Period, and who have used their albuterol rescue inhaler at least 2 days per week during the last 14 days of the Lead-in Period (≥ 4 uses total) will be randomized to continue the study and provided with study drug. Randomization will be stratified by Visit 1 FeNO level (\< 50 ppb / ≥ 50 ppb) and geographic region. Both albuterol/budesonide and albuterol will be supplied in identical inhalers and the maximum daily dose is the same for the 2 IMPs (6 doses, ie, 12 inhalations/day).

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 20, 2024
• Study Start: September 11, 2024
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPI/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (16)