Two doses of inhaled glycopyrronium added to BFF for children 4 to less than 12 with asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, randomized, double-blind, 3-period, 6-sequence crossover study compares two doses of glycopyrronium MDI to placebo MDI when added to background BFF MDI in children 4 to under 12 with asthma. After a 3-week run-in on BFF, participants will be randomized to three 3-week treatment periods receiving BFF plus glycopyrronium dose A, BFF plus glycopyrronium dose B, or BFF plus placebo, with each participant cycling through all three treatments. Lung function (FEV1) is the primary measure during the treatment periods, and safety is monitored with a follow-up visit 12 to 16 days after the last dose. The study is multi-center and double-blinded to reduce bias and allow within-patient comparisons across doses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Bakersfield, California, United States Recruiting
• Research Site
  Lancaster, California, United States Recruiting
• Research Site
  Long Beach, California, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Pembroke Pines, Florida, United States Recruiting
• Research Site
  Saint Cloud, Florida, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.