NCT06290102CompletedPhase 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
An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 26 Feb 2024
- Start date
- 16 May 2024
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Diseases
- Asthma
- NCT number
- NCT06290102
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 16 May 2024 to the primary completion date, 1 Oct 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial
- Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit
- NOTE- Additional criteria apply, please contact the investigator for more information
Other illness
- Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures
- Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product
Who the study is looking for
- Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit
- Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit
- Demonstrate acceptable inhalation technique with the training inhaler
- Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3
- Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg)
- Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device
- NOTE- Additional criteria apply, please contact the investigator for more information
Age in the registry: 4 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Teva Investigational Site 12001 Coordinator of this site? Confirm its status | Boerne | United States | Unknown status |
| Teva Investigational Site 12011 Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Teva Investigational Site 12008 Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Teva Investigational Site 12003 Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Teva Investigational Site 12002 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Teva Investigational Site 12005 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Teva Investigational Site 12007 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Teva Investigational Site 12010 Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Teva Investigational Site 12012 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Teva Investigational Site 12009 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.