NCT06290102Befejeződött1. fázis
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 4.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tényleges)
- Első benyújtás
- 2024. febr. 26.
- Kezdés
- 2024. máj. 16.
- Elsődleges befejezés
- 2024. okt. 1.
- Fő szponzor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Betegségek
- Asztma
- NCT-szám
- NCT06290102
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 30
- 2024. máj. 16. és az elsődleges befejezés (2024. okt. 1.) között
- 10 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 4 év – 11 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (10)
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