Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination… (NCT06290102) | Clinical Trial Compass
CompletedPhase 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
United States30 participantsStarted 2024-05-16
Plain-language 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
Who can participate
Age range
4 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial focused on how children's bodies absorb and process fluticasone propionate and albuterol together, what did the results tell us about whether the drug levels in kids aged 4 to 11 look safe compared to using fluticasone alone?
2This trial is now completed — does that mean the findings are published or available, and could the results change how you'd think about using a combination fluticasone and albuterol dry powder inhaler for my child's asthma?
3Because this was a pharmacokinetic study measuring things like drug concentration peaks and how long the medications stay in the body, does it tell us anything about whether the combination inhaler actually controls asthma better, or is that still unknown?
4Given that my child would be in the 4-to-11 age group this trial studied, are there any safety signals from the blood concentration data — like unexpectedly high peaks or slow clearance of either drug — that you'd want to factor into their current treatment plan?
5Are there standard approved treatments for my child's asthma that we should consider first, or do the results from this kind of early-phase study suggest the combination inhaler might be worth pursuing through newer or ongoing trials?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
Timeframe: Up to 24 hours postdose
2
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
Timeframe: Up to 24 hours postdose
3
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
Timeframe: Up to 24 hours postdose
4
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS
Timeframe: Up to 24 hours postdose
5
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate
Timeframe: Up to 24 hours postdose
6
AUC0-24 of Albuterol Sulfate
Timeframe: Up to 24 hours postdose
7
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
Trial details
NCT IDNCT06290102
SponsorTeva Branded Pharmaceutical Products R&D, Inc.