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NCT06290102 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
A Phase 1 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 10
- Study locations
NCT06290102: Completed Phase 1 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT06290102 is a Phase 1 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 30 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06290102, a Phase 1 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objectives of this study are: * To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma * To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI) * To compare the PK profiles of ABS between the 2 different strengths of TEV-56248 The secondary objective is: • To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI
Conditions Studied
Interventions
- DRUG TEV-56248
- DRUG Fp MDPI
Study Locations (10)
Florida
- Teva Investigational Site 12007 - Miami
- Teva Investigational Site 12005 - Miami
- Teva Investigational Site 12002 - Miami
Texas
- Teva Investigational Site 12001 - Boerne
- Teva Investigational Site 12009 - San Antonio
Alabama
- Teva Investigational Site 12010 - Mobile
California
- Teva Investigational Site 12003 - Long Beach
Louisiana
- Teva Investigational Site 12008 - Lafayette
Missouri
- Teva Investigational Site 12011 - Columbia
Oklahoma
- Teva Investigational Site 12012 - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 1 |
What the finished NCT06290102 record still lists
NCT06290102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which TEV-56248 is the first listed.
NCT06290102 lists 10 locations in 7 states (Florida, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT06290102 about?
NCT06290102 is a clinical study titled "Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old". The primary objectives of this study are: * To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants wi...
What is the current status of trial NCT06290102?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-05-16. Estimated completion is 2024-10-07.
What conditions does trial NCT06290102 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT06290102?
The interventions under investigation include: TEV-56248 (DRUG), Fp MDPI (DRUG).
Who is sponsoring clinical trial NCT06290102?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06290102 being conducted?
This trial has 10 study locations across Alabama, California, Florida, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06290102's enrollment target sits among peer trials
30 305th of 374 higher than 66 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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