Glycopyrronium + BFF for Asthma

(FAROS Trial)

Recruiting at 34 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: Inhaled corticosteroids

Must not be taking: LAMA, Beta-blockers, Systemic corticosteroids, Biologics

Disqualifiers: Life-threatening asthma, Cardiovascular disease, Respiratory infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must have a Childhood Asthma Control Test score ≥ 19

Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value

I use a regular inhaled steroid and another asthma controller medicine.

Exclusion Criteria

Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG

I do not have untreated narrow-angle glaucoma or serious bladder problems.

Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI

Timeline for a Trial Participant

Run-in

Participants undergo a 3-week run-in period to stabilize on background therapy

3 weeks

Treatment

Participants receive three 3-week treatment periods with different sequences of BFF MDI + GP MDI Dose A, BFF MDI + GP MDI Dose B, and BFF MDI + Placebo MDI

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glycopyrronium

How Is the Trial Designed?

Group I: Treatment Sequence CBA Experimental Treatment 3 Interventions

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

Group II: Treatment Sequence CAB Experimental Treatment 3 Interventions

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

Group III: Treatment Sequence BCA Experimental Treatment 3 Interventions

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

Group IV: Treatment Sequence BAC Experimental Treatment 3 Interventions

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

Group V: Treatment Sequence ACB Experimental Treatment 3 Interventions

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

Group VI: Treatment Sequence ABC Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology