ROTAHALER Device Optimization Study
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01890863
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will compare the pharmacokinetic (PK) of Fluticasone Propionate/Salmeterol combination (FSC) 100/50 micrograms (mcg) delivered via the capsule-based inhaler (Rdpi) relative to FSC 100/50 mcg delivered via the multi-dose dry powder inhaler (Ddpi) to establish whether the Rdpi inhaler has exposure (in terms of fluticasone propionate area under time concentration curve \[AUC\] and Salmeterol maximum concentration \[Cmax\]) no greater than 1.2500 compared to the Ddpi, sufficient to allow progression to Phase 3. This study will enroll 36 healthy adult male and female subjects and each subject will be allocated to one of two sequences and will participate in four treatment periods, receiving each of the treatments twice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 Fluticasone Propionate / Salmeterol Xinafoate DISKUS Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): BAAB, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose). Sequence 2 Fluticasone Propionate / Salmeterol Xinafoate ROTACAP Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): BAAB, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose). Sequence 1 Fluticasone Propionate / Salmeterol Xinafoate ROTACAP Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): ABBA, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose). Sequence 1 Fluticasone Propionate / Salmeterol Xinafoate DISKUS Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): ABBA, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose).
- Primary Outcome Measures
Name Time Method Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi PK samples will be collected at pre-dose, 5 minutes (mins), 10 mins, 30 mins, 1, 2, 4, 8, 10, and 12 hours post dose on Day 4 of each treatment period. PK Parameters include: area under the plasma fluticasone propionate concentration-time curve over dosing interval (AUCtau), salmeterol maximum plasma concentration-time curve on the last day of each study treatment period (Cmax).
- Secondary Outcome Measures
Name Time Method Vital sign measurement as measure of safety and tolerability. 35 days. Vital parameters include: systolic blood pressure, diastolic blood pressure, and pulse rate.
Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi PK samples will be collected at pre-dose, 5 minutes (mins), 10 mins, 30 mins, 1, 2, 4, 8, 10, and 12 hours post dose on Day 4 of each treatment period. PK Parameters include: area under the plasma salmeterol concentration-time curve over dosing interval (AUCtau), fluticasone propionate maximum plasma concentration-time curve on the last day of each study treatment period (Cmax), and fluticasone propionate and salmeterol time of occurence of Cmax (Tmax) on the last day of each treatment period (Day 4).
Number of participants with adverse events (AEs) as measure of safety and tolerability. 35 days. AEs will be collected from the start of study treatment and until the follow-up contact.
Laboratory parameters as a measure of safety and tolerability. 35 days Laboratory parameters include: hematology, clinical chemistry, urinalysis and additional parameters.
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Randwick, New South Wales, Australia