An Efficacy and Safety Study to Assess an Inhaled, Fixed-dose, Budesonide/Formoterol Fumarate in Participants Aged 4 to Less Than 12 Years of Age With Moderate Persistent Asthma (SOLAIR)

A 6-week, Double-blind, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Symbicort Aerosphere (BFF) 80/4.8 μg 2 Actuations BID Relative to Budesonide (BD) 80 μg 2 Actuations BID, in Participants Aged 4 to < 12 Years With Moderate Persistent Asthma

The purpose of this study is to evaluate whether budesonide and formoterol fumarate (BFF) metered-dose inhaler (MDI) is superior to BD MDI in improving lung function 1 hour post dose at Week 6 in children aged 4 to less than 12 years with moderate persistent asthma. The study will also assess safety of BFF MDI over a 6-week treatment period.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Combination product: BFF MDI; Combination product: BD MDI

Detailed Description

This is a 6-week, parallel-group, active-controlled, multicenter, study comparing BFF MDI 80/4.8 μg, 2 actuations twice daily (BID), to BD MDI 80 μg, 2 actuations BID.

The study will consist of:

• An enrollment visit (Visit 1a)
• A run-in period (beginning at Visit 1b): During the run-in period (2 weeks) participants will receive BD MDI BID as asthma maintenance therapy plus as needed short-acting β2-agonist (SABA) only.
• A randomization visit (Visit 2): At this visit, participants will be randomized in a 1:1 scheme to one of two treatment arms: (i) BFF 80/4.8 μg 2 actuations BID plus as needed SABA (ii) BD 80 μg 2 actuations BID plus as needed SABA.
• Visit 3 (2 weeks post randomization): A telephone call or tele-visit depending on participant convenience and preference to assess asthma status and adherence to study intervention.
• Visit 4 (6 weeks post randomization): At this visit, participants will receive their final dose of study intervention and lung function will be assessed. Following this visit, participants will switch back to their pre-study asthma maintenance therapy.
• Visit 5 (approximately 2 weeks post study completion) is a telephone call or tele-visit to record/follow-up any adverse events (AEs) experienced by the participant and to record any concomitant medications following Visit 5.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 1a.
• Had no asthma exacerbations requiring an escalation of inhaled medication regimen, systemic corticosteroids or hospitalization in the 6 months prior to Visit 1a.
• Body mass index (BMI) ≤95 percentile for age and sex.
• Female participants who have reached menarche must have a negative urine pregnancy test at all study site visits.
• If receiving immunotherapy per injection or sublingual, a participant must have been on a stable maintenance regimen for at least 6 weeks and be expected to remain on immunotherapy throughout the study.
• Require and are prescribed treatment with a consistent daily dose of inhaled ICS with or without LABA for at least 4 weeks prior to Visit 1a with doses including: Beclometasone dipropionate >200-400 μg/day (standard particle) or >100-200 μg/day (extra fine), BD dipronponate [dry-powder inhaler (DPI), or pressurized metered dose inhaler (pMDI), standard particle, hydrofluoroalkane (HFA)] >200 to 400 μg/day or BD (nebules) >500 to 1000 μg/day, Ciclesonide >80-160 μg/day, Fluticasone furoate 50 μg/day, Fluticasone propionate >100-200 μg/day, or Mometasone furoate 100 μg/day.
• Site-measured FEV1 at morning pre-bronchodilator visit must be ≥60% of the predicted normal, taken at least 6 hours after the last inhaled SABA, and at least 48 hours after the last inhaled LABA prior to Visit 1b. At Visit 2, pre-dose morning FEV1 should be ≥60% predicted normal value. Additionally, the FEV1 should not decrease by more than 10% in absolute value [liter [L]) from measurement at Visit 1b.
• Participants must demonstrate bronchodilator reversibility of ≥10% increase in FEV1 within 15-30 minutes after albuterol/salbutamol administration (90/100 μg per inhalation, 4 actuations with spacer) at the study site (repeatable once if initially failed), OR have historical reversibility of ≥10% within 1 year, OR show 10% FEV1 variability between site visits within 12 months with morning pre-bronchodilator FEV1 ≤95% predicted, OR if bronchodilator response is 7-<10% with post-bronchodilator FEV1 <95% predicted, meet at least one of: positive Methacholine Challenge Test (PC20 ≤16 mg/mL), peak expiratory flow (PEF) daily diurnal variability >13% over 2 weeks, positive exercise challenge test (FEV1 decrease >12%), or fractional exhaled nitric oxide ≥20 ppb despite ICS maintenance.
• Demonstrated ability to use any study devices [MDI with or without spacer, peak expiratory flow meter (PEFM)]. Participants aged 4 to 6 years are mandated to use a spacer. Participants older than 6 years of age must demonstrate adequate MDI technique or use a spacer if failed to demonstrate adequate technique after an objective testing.
• Had discontinued use of all asthma medications, including all formulations of β2-agonists, and used only the run-in medication and rescue medication provided since Visit 1b.

Exclusion Criteria:

• Had been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1a.
• Had any significant disease or disorder (eg, cardiovascular, pulmonary [other than asthma], gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or other disease or condition generally affecting lung function (eg, prematurity, congenital lung anomalies, tracheoesophageal fistula, bronchiectasis, chronic sinusitis).
• Had a known or suspected hypersensitivity to albuterol/salbutamol, or BD, or FF, and/or their excipients and/or have a severe hypersensitivity to milk proteins.
• Had any clinically relevant abnormal findings in physical examination, vital signs, abnormalities in electrocardiogram (ECG) or laboratory results at Visit 1a/Visit 1b.
• Had a respiratory infection or other viral/bacterial illness or were recovering from such an illness at the time of Visit 2.
• Loss of asthma stability between Visit 1 and Visit 2, characterized by ≥6 inhalations of SABA within any 24-hour period, ≥4 inhalations of SABA within any 4-hour period, night-time awakenings due to asthma on ≥2 nights per week, daytime symptoms on >2 days per week or limitation in normal activity on ≥2 days per week, ≥20% decrease in PEF from screening baseline, or any unscheduled physician, urgent care, or emergency department visit for asthma.
• Have a planned hospitalization at any time during the study.
• Receiving treatment with a β-blocker (including eye-drops).
• Had taken any other monoclonal or polyclonal antibody therapy, for any reason within the 6 months prior to Visit 1b.
• Had been treated with systemic corticosteroids (eg oral, parenteral, or rectal).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide and formoterol fumarate metered-dose inhaler (BFF MDI); Participants will receive oral inhalations of BFF MDI 80/4.8 μg as 2 actuations BID.	Combination product: BFF MDI; BFF pressurized inhalation suspension will be administered as 2 oral actuations.; Other Names: Symbicort Aerosphere
Active Comparator: Budesonide metered-dose inhaler (BD MDI); Participants will receive oral inhalations of BD MDI 80 μg as 2 actuations BID.	Combination product: BD MDI; BD pressurized inhalation suspension will be administered as 2 oral actuations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 1 hour post dose forced expiratory volume in the first second (FEV1) at Week 6	The effect of BFF MDI 80/4.8 μg 2 actuations BID relative to BD MDI 80 μg 2 actuations BID on post dose lung function at Week 6 in participants 4 to less than 12 years of age with moderate persistent asthma will be assessed.	At Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 1 hour post dose FEV1 at Day 1	The effect of BFF MDI 80/4.8 μg 2 actuations BID relative to BD MDI 80 μg 2 actuations BID on post dose lung function at Day 1 in participants 4 to less than 12 years of age with moderate persistent asthma will be assessed.	On Day 1
Change from baseline in 15 minutes post dose FEV1 at Week 6	The effect of BFF MDI 80/4.8 μg 2 actuations BID relative to BD MDI 80 μg 2 actuations BID on post dose lung function at Week 6 in participants 4 to less than 12 years of age with moderate persistent asthma will be assessed.	At Week 6
Change from baseline in morning pre-dose FEV1 at Week 6	The effect of BFF MDI 80/4.8 μg 2 actuations BID relative to BD MDI 80 μg 2 actuations BID on pre-dose lung function at Week 6 in participants 4 to less than 12 years of age with moderate persistent asthma will be assessed.	At Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to discontinuation (DAEs)	Safety and tolerability of BFF MDI 80/4.8 μg 2 actuations BID versus BD MDI 80 μg 2 actuations BID in participants 4 to less than 12 years of age with moderate persistent asthma will be compared.	From run-in period (Visit 1b) and up to the follow-up telephone call [2 weeks (± 5 days) after last dose of study intervention] (up to 10 weeks after the start of run-in)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029

Study Registration Dates

• First Submitted: November 6, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Inhaled corticosteroids; Combination therapy; Budesonide; Formoterol fumarate; Long-acting β2-agonist; Short-acting β2-agonist
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: D7820C00004; 5570196 (Other Identifier: Pediatric Study Plan Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes