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

Part of paid clinical trials in Bakersfield, California.

Sponsor
AstraZeneca
Study ID
NCT07525375
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • GP MDI — COMBINATION_PRODUCT
    GP MDI will be administered via oral inhalation twice daily (BID).
  • BFF MDI — COMBINATION_PRODUCT
    BFF MDI will be administered via oral inhalation BID.
  • Placebo MDI — COMBINATION_PRODUCT
    Placebo MDI will be adminsitered via oral inhalation BID.

Study Details

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.

Key Dates

Start date
Apr 14, 2026
Status verified
Apr 2026
Primary completion
May 23, 2029
Completion
May 23, 2029

Study Design

Enrollment
69 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence ABC
    Participants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each.
  • Experimental: Treatment Sequence BCA
    Participants will receive three treatments in sequence: Treatment B, Treatment C followed by Treatment A for 3 weeks each.
  • Experimental: Treatment Sequence CAB
    Participants will receive three treatments in sequence: Treatment C, Treatment A followed by Treatment B for 3 weeks each.
  • Experimental: Treatment Sequence ACB
    Participants will receive three treatments in sequence: Treatment A, Treatment C followed by Treatment B for 3 weeks each.
  • Experimental: Treatment Sequence BAC
    Participants will receive three treatments in sequence: Treatment B, Treatment A followed by Treatment C for 3 weeks each.
  • Experimental: Treatment Sequence CBA
    Participants will receive three treatments in sequence: Treatment C, Treatment B followed by Treatment A for 3 weeks each.

Primary Outcome Measure

Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT) [ Time Frame: at 3 weeks ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteBakersfieldCalifornia93301-
Research SiteLong BeachCalifornia90806-
Research SiteSan DiegoCalifornia92123-
Research SiteMiamiFlorida33125-
Research SitePembroke PinesFlorida33026-
Research SiteOwensboroKentucky42301-
Research SiteLafayetteLouisiana70508-
Research SiteBostonMassachusetts02114-
Research SiteColumbiaMissouri65203-
Research SiteCincinnatiOhio45229-
Research SiteOklahoma CityOklahoma73120-

Find similar trials in Bakersfield, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Research Site· Bakersfield, CAResearch Site· Long Beach, CAResearch Site· San Diego, CAResearch Site· Miami, FLResearch Site· Pembroke Pines, FLResearch Site· Owensboro, KY

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