NCT07525375

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
34mo left

Started Apr 2026

Longer than P75 for phase_2 asthma

Geographic Reach
7 countries

39 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026May 2029

First Submitted

Initial submission to the registry

April 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2029

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

April 7, 2026

Last Update Submit

April 17, 2026

Conditions

Asthma

Keywords

Oral inhalationMetered dose inhalerAdd-on therapyInhaled corticosteroidLong-acting β2-agonistsLong-acting muscarinic antagonistLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT)

    Evaluate the effect of 2 different GP MDI doses relative to placebo MDI as an add-on treatment to BFF MDI on lung function in 4 to less than 12 years old participants with asthma.

    at 3 weeks

Secondary Outcomes (1)

  • Change from baseline in morning pre-dose trough FEV1 at EOT

    at 3 weeks

Other Outcomes (1)

  • Number of participants with adverse events (AEs) and Adverse events of special interest (AESIs)

    Up to Follow-up (2 weeks after last dose)(Approximately 14 weeks)

Study Arms (6)

Treatment Sequence ABC

EXPERIMENTAL

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

Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI

Treatment Sequence BCA

EXPERIMENTAL

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

Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI

Treatment Sequence CAB

EXPERIMENTAL

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

Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI

Treatment Sequence ACB

EXPERIMENTAL

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

Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI

Treatment Sequence BAC

EXPERIMENTAL

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

Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI

Treatment Sequence CBA

EXPERIMENTAL

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

Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI

Interventions

GP MDICOMBINATION_PRODUCT

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

Treatment Sequence ABCTreatment Sequence ACBTreatment Sequence BACTreatment Sequence BCATreatment Sequence CABTreatment Sequence CBA
BFF MDICOMBINATION_PRODUCT

BFF MDI will be administered via oral inhalation BID.

Treatment Sequence ABCTreatment Sequence ACBTreatment Sequence BACTreatment Sequence BCATreatment Sequence CABTreatment Sequence CBA
Placebo MDICOMBINATION_PRODUCT

Placebo MDI will be adminsitered via oral inhalation BID.

Treatment Sequence ABCTreatment Sequence ACBTreatment Sequence BACTreatment Sequence BCATreatment Sequence CABTreatment Sequence CBA

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Research Site

Bakersfield, California, 93301, United States

NOT YET RECRUITING

Research Site

Long Beach, California, 90806, United States

NOT YET RECRUITING

Research Site

San Diego, California, 92123, United States

NOT YET RECRUITING

Research Site

Miami, Florida, 33125, United States

NOT YET RECRUITING

Research Site

Pembroke Pines, Florida, 33026, United States

NOT YET RECRUITING

Research Site

Owensboro, Kentucky, 42301, United States

RECRUITING

Research Site

Lafayette, Louisiana, 70508, United States

NOT YET RECRUITING

Research Site

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Research Site

Columbia, Missouri, 65203, United States

NOT YET RECRUITING

Research Site

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Research Site

Oklahoma City, Oklahoma, 73120, United States

NOT YET RECRUITING

Research Site

Buenos Aires, C1122, Argentina

NOT YET RECRUITING

Research Site

CABA, 1426, Argentina

NOT YET RECRUITING

Research Site

La Plata, B1900AXI, Argentina

NOT YET RECRUITING

Research Site

Lanús Este, B1824KAJ, Argentina

NOT YET RECRUITING

Research Site

Lobos, 7240, Argentina

NOT YET RECRUITING

Research Site

Mar del Plata, B7600, Argentina

NOT YET RECRUITING

Research Site

Mendoza, 5500, Argentina

NOT YET RECRUITING

Research Site

Mendoza, M5500, Argentina

NOT YET RECRUITING

Research Site

Rosario, 2000, Argentina

NOT YET RECRUITING

Research Site

Rosario, S2000CVD, Argentina

NOT YET RECRUITING

Research Site

San Juan Bautista, 1888, Argentina

NOT YET RECRUITING

Research Site

Santa Fe, 3000, Argentina

NOT YET RECRUITING

Research Site

Brno, 65691, Czechia

NOT YET RECRUITING

Research Site

Prague, 15006, Czechia

NOT YET RECRUITING

Research Site

Debrecen, 4032, Hungary

NOT YET RECRUITING

Research Site

Orosháza, 5900, Hungary

NOT YET RECRUITING

Research Site

Szeged, 6720, Hungary

NOT YET RECRUITING

Research Site

Székesfehérvár, 8000, Hungary

NOT YET RECRUITING

Research Site

Szigetvár, 7900, Hungary

NOT YET RECRUITING

Research Site

Apodaca, 64620, Mexico

NOT YET RECRUITING

Research Site

Guadalajara, 44130, Mexico

NOT YET RECRUITING

Research Site

San Juan, 00909, Mexico

NOT YET RECRUITING

Research Site

Lodz, 90-329, Poland

NOT YET RECRUITING

Research Site

Tarnów, 33-100, Poland

NOT YET RECRUITING

Research Site

Belgrade, 11000, Serbia

NOT YET RECRUITING

Research Site

Belgrade, 11040, Serbia

NOT YET RECRUITING

Research Site

Belgrade, 11070, Serbia

NOT YET RECRUITING

Research Site

Novi Sad, 21000, Serbia

NOT YET RECRUITING

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 13, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

May 23, 2029

Study Completion (Estimated)

May 23, 2029

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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 athttps://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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

ME(3)CZ(2)AR(12)HU(5)PL(2)US(11)SE(4)