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)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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 design
Primary purpose
Allocation
Interventional model
Masking
69 participants in 6 patient groups
Trial contacts and locations
Loading...
Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal