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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 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 11 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how two doses of inhaled glycopyrronium affect breathing in children ages 4 to 11 with asthma. Children will use either glycopyrronium or a placebo inhaler (no active medicine), along with a BFF inhaler.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 4 to 11 and have a record of asthma diagnosed by a doctor.
  • Have been regularly using an inhaled steroid and one other asthma control medicine at a steady dose.
  • Have a Childhood Asthma Control Test score of 19 or higher.
  • Have an FEV1 breathing test result of 95% or less of the expected normal value before taking medicine to open the airways.
  • Have a body mass index (BMI, a measure of weight compared with height) at or below the 95th percentile for age.
  • Weigh at least 14 kilograms (about 31 pounds).
  • If menstrual periods have started, have a negative urine pregnancy test.
  • During the study's preparation period, use only BFF twice a day and albuterol or salbutamol as needed for asthma.

Who can't join

  • Have had life-threatening asthma, such as an attack involving a breathing tube with high blood carbon dioxide, stopped breathing, seizures from low oxygen, or fainting; or have been hospitalized for asthma.
  • Have another serious disease, or important abnormal findings on an exam, blood tests, vital signs, or a heart rhythm test.
  • Have poorly treated narrow-angle glaucoma (an eye pressure problem), vision changes, bladder problems, trouble passing urine, or another condition that makes anticholinergic medicines unsafe.
  • Use a long-acting muscarinic antagonist (LAMA, a type of airway-opening medicine), a beta-blocker that acts throughout the body, or steroids taken by mouth or injection.
  • Have a breathing infection treated with antibiotics.
  • Have a known allergy to beta-2 agonists, steroids, anticholinergics, or any ingredient in the study inhalers.
  • Cannot safely pause quick-relief inhalers or other asthma medicines, or regularly use a nebulizer (a machine that turns asthma medicine into mist).
  • Use a biologic medicine, including an experimental one, or medicines that change or weaken the immune system.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (15)

CA

FL

KY

LA

MA

MO

OH

OK

TX