A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma (FAROS)

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) Versus Placebo in Participants of 4 to Less Than 12 Years of Age With Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Combination product: GP MDI; Combination product: BFF MDI; Combination product: Placebo MDI

Detailed Description

This is a Phase II, multi-center, randomized, double-blind, 3-period, 6-sequence crossover study evaluating two doses of GP Metered-Dose Inhaler (MDI) compared with placebo MDI as add-on therapy to BFF MDI.

The study comprises a 3-week run-in period, followed by three 3-week treatment periods where participants will be randomized to one of six treatment sequences, and a safety follow-up visit 12 to 16 days after the last dose of study intervention.

The treatment periods are as follows:

• Treatment A: BFF MDI + GP MDI Dose A
• Treatment B: BFF MDI + GP MDI Dose B
• Treatment C: BFF MDI + Placebo MDI

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1122
    • Not yet recruiting
    • Research Site
  • CABA, Argentina, 1426
    • Not yet recruiting
    • Research Site
  • La Plata, Argentina, B1900AXI
    • Not yet recruiting
    • Research Site
  • Lanús Este, Argentina, B1824KAJ
    • Not yet recruiting
    • Research Site
  • Lobos, Argentina, 7240
    • Not yet recruiting
    • Research Site
  • Mar del Plata, Argentina, B7600
    • Not yet recruiting
    • Research Site
  • Mendoza, Argentina, M5500
    • Not yet recruiting
    • Research Site
  • Mendoza, Argentina, 5500
    • Not yet recruiting
    • Research Site
  • Rosario, Argentina, 2000
    • Not yet recruiting
    • Research Site
  • Rosario, Argentina, S2000CVD
    • Not yet recruiting
    • Research Site
  • San Juan Bautista, Argentina, 1888
    • Not yet recruiting
    • Research Site
  • Santa Fe, Argentina, 3000
    • Not yet recruiting
    • Research Site
• Czechia
  • Brno, Czechia, 65691
    • Not yet recruiting
    • Research Site
  • Prague, Czechia, 15006
    • Not yet recruiting
    • Research Site
• Hungary
  • Debrecen, Hungary, 4032
    • Not yet recruiting
    • Research Site
  • Orosháza, Hungary, 5900
    • Not yet recruiting
    • Research Site
  • Szeged, Hungary, 6720
    • Not yet recruiting
    • Research Site
  • Szigetvár, Hungary, 7900
    • Not yet recruiting
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Not yet recruiting
    • Research Site
• Mexico
  • Apodaca, Mexico, 64620
    • Not yet recruiting
    • Research Site
  • Guadalajara, Mexico, 44130
    • Not yet recruiting
    • Research Site
  • San Juan, Mexico, 00909
    • Not yet recruiting
    • Research Site
• Poland
  • Lodz, Poland, 90-329
    • Not yet recruiting
    • Research Site
  • Tarnów, Poland, 33-100
    • Not yet recruiting
    • Research Site
• Serbia
  • Belgrade, Serbia, 11000
    • Not yet recruiting
    • Research Site
  • Belgrade, Serbia, 11070
    • Not yet recruiting
    • Research Site
  • Belgrade, Serbia, 11040
    • Not yet recruiting
    • Research Site
  • Novi Sad, Serbia, 21000
    • Not yet recruiting
    • Research Site
• United States
  • California
    • Bakersfield, California, United States, 93301
      • Not yet recruiting
      • Research Site
    • Long Beach, California, United States, 90806
      • Not yet recruiting
      • Research Site
    • San Diego, California, United States, 92123
      • Not yet recruiting
      • Research Site
  • Florida
    • Miami, Florida, United States, 33125
      • Not yet recruiting
      • Research Site
    • Pembroke Pines, Florida, United States, 33026
      • Not yet recruiting
      • Research Site
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Recruiting
      • Research Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Not yet recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Not yet recruiting
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Not yet recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence ABC; Participants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each.	Combination product: GP MDI; GP MDI will be administered via oral inhalation twice daily (BID).; Combination product: BFF MDI; BFF MDI will be administered via oral inhalation BID.; Combination product: Placebo MDI; Placebo MDI will be adminsitered via oral inhalation BID.
Experimental: Treatment Sequence BCA; Participants will receive three treatments in sequence: Treatment B, Treatment C followed by Treatment A for 3 weeks each.	Combination product: GP MDI; GP MDI will be administered via oral inhalation twice daily (BID).; Combination product: BFF MDI; BFF MDI will be administered via oral inhalation BID.; Combination product: Placebo MDI; Placebo MDI will be adminsitered via oral inhalation BID.
Experimental: Treatment Sequence CAB; Participants will receive three treatments in sequence: Treatment C, Treatment A followed by Treatment B for 3 weeks each.	Combination product: GP MDI; GP MDI will be administered via oral inhalation twice daily (BID).; Combination product: BFF MDI; BFF MDI will be administered via oral inhalation BID.; Combination product: Placebo MDI; Placebo MDI will be adminsitered via oral inhalation BID.
Experimental: Treatment Sequence ACB; Participants will receive three treatments in sequence: Treatment A, Treatment C followed by Treatment B for 3 weeks each.	Combination product: GP MDI; GP MDI will be administered via oral inhalation twice daily (BID).; Combination product: BFF MDI; BFF MDI will be administered via oral inhalation BID.; Combination product: Placebo MDI; Placebo MDI will be adminsitered via oral inhalation BID.
Experimental: Treatment Sequence BAC; Participants will receive three treatments in sequence: Treatment B, Treatment A followed by Treatment C for 3 weeks each.	Combination product: GP MDI; GP MDI will be administered via oral inhalation twice daily (BID).; Combination product: BFF MDI; BFF MDI will be administered via oral inhalation BID.; Combination product: Placebo MDI; Placebo MDI will be adminsitered via oral inhalation BID.
Experimental: Treatment Sequence CBA; Participants will receive three treatments in sequence: Treatment C, Treatment B followed by Treatment A for 3 weeks each.	Combination product: GP MDI; GP MDI will be administered via oral inhalation twice daily (BID).; Combination product: BFF MDI; BFF MDI will be administered via oral inhalation BID.; Combination product: Placebo MDI; Placebo MDI will be adminsitered via oral inhalation BID.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in morning pre-dose trough FEV1 at EOT	Evaluate the effect of 2 different GP MDI doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in 4 to less than 12 years old participants with asthma.	at 3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) and Adverse events of special interest (AESIs)	To evaluate the safety profile of GP MDI relative to placebo MDI as add-on treatment to BFF MDI in participants aged 4 to less than 12 years.	Up to Follow-up (2 weeks after last dose)(Approximately 14 weeks)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): May 23, 2029
• Study Completion (Estimated): May 23, 2029

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lung Diseases; Inhaled corticosteroid; Metered dose inhaler; Oral inhalation; Long-acting muscarinic antagonist; Add-on therapy; Long-acting β2-agonists
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases; Asthma
• Other Study ID Numbers: D5982C00015; 2025-524914-26-00 (Other Identifier: EU CT Number); EMEA-002063-PIP01-16 (Other Identifier: Pediatric Investigational Plan Numbers)

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 athttps://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: No