Recruiting
Phase 2

BFF with MDI

Sponsor:

AstraZeneca

Code:

NCT07525375

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 4 - 11

Healthy Volunteers: Not accepted

Interventions

GP MDI

BFF MDI

Placebo MDI

Study Details

Brief summary:

The purpose of this study is to evaluate the effect of 2 different GP metered dose inhaler (MDI) doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in participants 4 to less than 12 years of age with asthma.

Conditions

Asthma

Study ID

NCT07525375

Start date

Apr 14, 2026

Status verified date

Aug, 2026

Completion date

May 23, 2029

Anticipated

Primary completion date

May 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 11

Healthy Volunteers: Not accepted

Main Inclusion Criteria:

  • Participants who have a documented history of physician-diagnosed asthma
  • Participants who have been using a stable and regular inhaled corticosteroid plus one additional asthma controller medication.
  • Participants must have a Childhood Asthma Control Test score ≥ 19.
  • Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value.
  • Body mass index (BMI) ≤ 95 percentile for age and body weight of ≥ 14 kg or higher.
  • Female participants who experience menarche must have a negative urine pregnancy test.
  • Received no asthma medication other than run-in BFF MDI BID and albuterol/salbutamol as needed.

Main Exclusion Criteria:

  • Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
  • Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG.
  • Hospitalization for asthma
  • Narrow-angle glaucoma not adequately treated and/or change in vision, bladder dysfunction, bladder outlet obstruction/urinary retention or any other conditions where anticholinergic treatment is contraindicated and may be relevant.
  • Use of Long-acting muscarinic antagonist (LAMA), either alone or as part of an inhaled combination therapy.
  • Current use of any systemic beta-blockers.
  • Respiratory infection involving antibiotic treatment.
  • Systemic corticosteroid use for any reason (including asthma exacerbations).
  • Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI.
  • Participants who are medically unable to withhold their short-acting bronchodilators and other asthma medications.
  • Any use of marketed (eg, omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic.
  • Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
  • Use of any immunomodulators or immunosuppressive medication.

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Sequence ABC

Participants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each.

experimental: Treatment Sequence BCA

Participants will receive three treatments in sequence: Treatment B, Treatment C followed by Treatment A for 3 weeks each.

experimental: Treatment Sequence CAB

Participants will receive three treatments in sequence: Treatment C, Treatment A followed by Treatment B for 3 weeks each.

experimental: Treatment Sequence ACB

Participants will receive three treatments in sequence: Treatment A, Treatment C followed by Treatment B for 3 weeks each.

experimental: Treatment Sequence BAC

Participants will receive three treatments in sequence: Treatment B, Treatment A followed by Treatment C for 3 weeks each.

experimental: Treatment Sequence CBA

Participants will receive three treatments in sequence: Treatment C, Treatment B followed by Treatment A for 3 weeks each.

Interventions

GP MDI

GP MDI will be administered via oral inhalation twice daily (BID).

BFF MDI

BFF MDI will be administered via oral inhalation BID.

Placebo MDI

Placebo MDI will be adminsitered via oral inhalation BID.

Primary outcome measure

  • Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT) [ Time Frame: at 3 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Bakersfield, California, United States, 93301

Research Site

Recruiting

Lancaster, California, United States, 93534

Research Site

Recruiting

Long Beach, California, United States, 90806

Research Site

Recruiting

Miami, Florida, United States, 33186

Research Site

Recruiting

Pembroke Pines, Florida, United States, 33026

Research Site

Recruiting

Saint Cloud, Florida, United States, 34769

Research Site

Recruiting

Owensboro, Kentucky, United States, 42301

Research Site

Recruiting

Lafayette, Louisiana, United States, 70508

Research Site

Recruiting

Columbia, Missouri, United States, 65203

Research Site

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Research Site

Recruiting

Lewisville, Texas, United States, 75067

More Information

Sponsor

AstraZeneca

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Oral inhalation
  • Metered dose inhaler
  • Add-on therapy
  • Inhaled corticosteroid
  • Long-acting β2-agonists
  • Long-acting muscarinic antagonist
  • Lung Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-13. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.