A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma

Part of paid clinical trials in Long Beach, California.

Sponsor
AstraZeneca
Study ID
NCT07433569
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Budesonide/formoterol fumarate Aerosphere — COMBINATION_PRODUCT
    Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.
  • Budesonide/formoterol fumarate pMDI — COMBINATION_PRODUCT
    Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.

Study Details

The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.

Key Dates

Start date
Mar 5, 2026
Status verified
May 2026
Primary completion
Oct 23, 2026
Completion
Oct 23, 2026

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence AB
    In study period 1, participants will receive a single dose of treatment A (test formulation) and in study period 2, participants will receive a single dose of treatment B (reference formulation).
  • Experimental: Sequence BA
    In study period 1, participants will receive a single dose of treatment B (reference formulation) and in study period 2, participants will receive a single dose of treatment A (test formulation).

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose ]

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteLong BeachCalifornia90815-
Research SiteMiamiFlorida33175-
Research SiteLafayetteLouisiana70508-
Research SiteToledoOhio43617-
Research SiteBoerneTexas78006-
Research SiteEl PasoTexas79903-

Find similar trials in Long Beach, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Research Site· Long Beach, CAResearch Site· Miami, FLResearch Site· Lafayette, LAResearch Site· Toledo, OHResearch Site· Boerne, TXResearch Site· El Paso, TX

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