AsthmaPhase 2FAROSNCT07525375
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
A Phase 2 study testing GP MDI and BFF MDI in people with Asthma, run by AstraZeneca at 44 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- GP MDI and BFF MDI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 44 sitesin 7 countries
- Study dates
- 14 Apr 2026to 23 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
44 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
44 sites in 7 countries
United States15 sites, 15 recruiting
- Recruiting
Research Site
Bakersfield, California, 93301
- Not yet recruiting
Research Site
Boston, Massachusetts, 02114
- Not yet recruiting
Research Site
Cincinnati, Ohio, 45229
- Recruiting
Research Site
Columbia, Missouri, 65203
- Recruiting
Research Site
Lafayette, Louisiana, 70508
- Recruiting
Research Site
Lancaster, California, 93534
- Recruiting
Research Site
Lewisville, Texas, 75067
- Recruiting
Research Site
Long Beach, California, 90806
- Recruiting
Research Site
Miami, Florida, 33125
- Recruiting
Research Site
Oklahoma City, Oklahoma, 73120
- Recruiting
Research Site
Owensboro, Kentucky, 42301
- Recruiting
Research Site
Pembroke Pines, Florida, 33026
- Recruiting
Research Site
Saint Cloud, Florida, 34769
- Recruiting
Research Site
San Antonio, Texas, 78249
- Not yet recruiting
Research Site
San Diego, California, 92123
Argentina12 sites, 12 recruiting
- Recruiting
Research Site
Buenos Aires, C1122
- Recruiting
Research Site
CABA, 1426
- Not yet recruiting
Research Site
La Plata, B1900AXI
- Not yet recruiting
Research Site
Lanús Este, B1824KAJ
- Not yet recruiting
Research Site
Lobos, 7240
- Not yet recruiting
Research Site
Mar del Plata, B7600
- Not yet recruiting
Research Site
Mendoza, 5500
- Recruiting
Research Site
Mendoza, M5500
- Not yet recruiting
Research Site
Rosario, 2000
- Recruiting
Research Site
Rosario, S2000CVD
- Not yet recruiting
Research Site
San Juan Bautista, 1888
- Not yet recruiting
Research Site
Santa Fe, 3000
Hungary6 sites, 6 recruiting
- Not yet recruiting
Research Site
Budapest, 1033
- Recruiting
Research Site
Debrecen, 4032
- Not yet recruiting
Research Site
Orosháza, 5900
- Recruiting
Research Site
Szeged, 6720
- Not yet recruiting
Research Site
Székesfehérvár, 8000
- Recruiting
Research Site
Szigetvár, 7900
Serbia4 sites, 4 recruiting
- Not yet recruiting
Research Site
Belgrade, 11000
- Not yet recruiting
Research Site
Belgrade, 11040
- Not yet recruiting
Research Site
Belgrade, 11070
- Not yet recruiting
Research Site
Novi Sad, 21000
Mexico3 sites, 3 recruiting
- Not yet recruiting
Research Site
Apodaca, 64620
- Not yet recruiting
Research Site
Guadalajara, 44130
- Not yet recruiting
Research Site
San Juan, 00909
Czechia2 sites, 2 recruiting
- Not yet recruiting
Research Site
Brno, 65691
- Not yet recruiting
Research Site
Prague, 15006
Poland2 sites, 2 recruiting
- Recruiting
Research Site
Lodz, 90-329
- Not yet recruiting
Research Site
Tarnów, 33-100
About this study
Official title: 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.
Read the 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
- Conditions
- Asthma
- Being tested
- GP MDI, BFF MDI, Placebo MDI
- Keywords
- Oral inhalation, Metered dose inhaler, Add-on therapy, Inhaled corticosteroid, Long-acting β2-agonists, Long-acting muscarinic antagonist, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP MDICombination product
GP MDI will be administered via oral inhalation twice daily (BID).
BFF MDICombination product
BFF MDI will be administered via oral inhalation BID.
Placebo MDICombination product
Placebo MDI will be adminsitered via oral inhalation BID.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence ABC | Experimental | Participants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each. Receives: Combination Product: GP MDI; Combination Product: BFF MDI; Combination 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. Receives: Combination Product: GP MDI; Combination Product: BFF MDI; Combination 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. Receives: Combination Product: GP MDI; Combination Product: BFF MDI; Combination 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. Receives: Combination Product: GP MDI; Combination Product: BFF MDI; Combination 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. Receives: Combination Product: GP MDI; Combination Product: BFF MDI; Combination 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. Receives: Combination Product: GP MDI; Combination Product: BFF MDI; Combination Product: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 weeks
Secondary outcomes (1)
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.
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start14 Apr 2026
- Primary completion23 May 2029 (estimated)
- Study completion23 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525375
- Sponsor's protocol ID
- D5982C00015
- Other IDs
- 2025-524914-26-00, EMEA-002063-PIP01-16, 2025
- Acronym
- FAROS
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07525375
- Acronym / sponsor ID
- FAROS / D5982C00015
- Conditions
- Asthma
- Keywords
- Oral inhalation, Metered dose inhaler, Add-on therapy, Inhaled corticosteroid, Long-acting β2-agonists, Long-acting muscarinic antagonist, Lung Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 23 May 2029 (estimated)
- Study completion
- 23 May 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence ABC | Experimental | Combination Product: GP MDI, Combination Product: BFF MDI, Combination Product: Placebo MDIParticipants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each. |
| Treatment Sequence BCA | Experimental | Combination Product: GP MDI, Combination Product: BFF MDI, Combination Product: Placebo MDIParticipants will receive three treatments in sequence: Treatment B, Treatment C followed by Treatment A for 3 weeks each. |
| Treatment Sequence CAB | Experimental | Combination Product: GP MDI, Combination Product: BFF MDI, Combination Product: Placebo MDIParticipants will receive three treatments in sequence: Treatment C, Treatment A followed by Treatment B for 3 weeks each. |
| Treatment Sequence ACB | Experimental | Combination Product: GP MDI, Combination Product: BFF MDI, Combination Product: Placebo MDIParticipants will receive three treatments in sequence: Treatment A, Treatment C followed by Treatment B for 3 weeks each. |
| Treatment Sequence BAC | Experimental | Combination Product: GP MDI, Combination Product: BFF MDI, Combination Product: Placebo MDIParticipants will receive three treatments in sequence: Treatment B, Treatment A followed by Treatment C for 3 weeks each. |
| Treatment Sequence CBA | Experimental | Combination Product: GP MDI, Combination Product: BFF MDI, Combination Product: Placebo MDIParticipants will receive three treatments in sequence: Treatment C, Treatment B followed by Treatment A for 3 weeks each. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP MDIGP MDI will be administered via oral inhalation twice daily (BID). | Combination product | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
| BFF MDIBFF MDI will be administered via oral inhalation BID. | Combination product | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
| Placebo MDIPlacebo MDI will be adminsitered via oral inhalation BID. | Combination product | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
Primary outcome
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
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.
1 secondary outcome
Change from baseline in morning pre-dose trough FEV1 at EOT
Time frame: at 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GP MDI and BFF MDI in people with Asthma, run by AstraZeneca at 44 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Argentina, Hungary, Serbia, Mexico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.