Glycopyrronium for Children Aged 4-12 with Asthma

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

Recruiting Phase 2 Interventional Study
Asthma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
4 – 11
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
69 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for children aged 4 to less than 12 who have asthma. Participants will take a medication called glycopyrronium along with another asthma treatment to see how it helps lung function.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with asthma.
  • I use an inhaled corticosteroid and one other asthma medication regularly.
  • I have a Childhood Asthma Control Test score of 19 or higher.
  • My pre-bronchodilator FEV1 is 95% or less of what is expected for my age.
  • I weigh at least 14 kg.
  • If I am a girl who has started my period, I have had a negative pregnancy test.
  • I have not taken any asthma medications other than those required for this study.

You may not be able to join if

  • I have had a life-threatening asthma episode requiring intubation.
  • I have a significant health issue like heart or kidney disease.
  • I have had any abnormal findings in my physical exams or tests.
  • I have been hospitalized for asthma.
  • I have narrow-angle glaucoma or other issues that make certain treatments unsafe.
  • I am currently using long-acting muscarinic antagonists or beta-blockers.
  • I have a respiratory infection needing antibiotics.
  • I take any systemic corticosteroids for asthma or other conditions.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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.

Trial Locations
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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. *…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT