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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

NCT07525375 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

COMBINATION_PRODUCT

Placebo MDI

Placebo MDI will be adminsitered via oral inhalation BID.

COMBINATION_PRODUCT

BFF MDI

BFF MDI will be administered via oral inhalation BID.

COMBINATION_PRODUCT

GP MDI

GP MDI will be administered via oral inhalation twice daily (BID).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-14
Primary Completion
2029-05-23
Completion
2029-05-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Czechia
  • Hungary
  • Mexico
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07525375 on ClinicalTrials.gov