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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Branded Pharmaceutical Products R&D, Inc.
The planned treatment duration for this trial is approximately 1.5 to 2 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.
Age
4–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product
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
Clareo Health | 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
