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)

November 6, 2026 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in 1 hour post dose FEV1 at Day 1
Time Frame: On 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
Time Frame: 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)

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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