Asthma
Conditions
Keywords
Healthy Subjects, SERETIDE, Pharmocokinetics, FLIXOTIDE, VENTOLIN Mini-Spacer
Brief summary
The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of this exploratory study is to investigate whether the systemic exposure for fluticasone propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer for both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four study periods in the study and all participants will receive four study treatments during the study. The total duration of study including screening, treatment period, washout period, and follow-up period will be 58 days. Study is planned to enroll 20 healthy subjects. VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark of GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.
Interventions
DEVICEVENTOLIN Mini-Spacer
VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler
DEVICEAerochamber Plus spacer
Aerochamber Plus spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac testing. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight \>=50 kilogram (kg) and body mass index within the range 19 - 34 kg/meter\^2 (inclusive). * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy \[for this definition, documented refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\]; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 21.7 international unit/Liter (L) and estradiol \<110 picomoles/L is confirmatory\]. \[Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\] Child-bearing potential with negative pregnancy test as determined by urine or serum human Chorionic Gonadotropin (hCG) test at screening or prior to dosing AND Agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 2 days post-last dose. OR has only same-sex partners, when this is her preferred and usual lifestyle. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Agrees to provide written consent to have information entered into The Over-volunteering Prevention System TOPS. * Alanine aminotransferase, alkaline phosphatase and bilirubin \<=1.5xupper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Based on single or averaged QT duration corrected for heart rate by Fridericia's formula (QTcF) values of single electrocardiograms (ECGs) obtained over a brief recording period: QTcF \<450 milliseconds (msec).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma drug concentration versus time curve over 24 hours (AUC[0-24h]) for FP | Samples will be collected at: pre-dose, and 5 minutes (m), 10m, 30m, 45, 1 hour (h), 1.5h, 2h, 4h, 8h, 10h, 12 h, 16h and 24 h post dose in each period | Blood samples will be collected for pharmacokinetic analysis of Fluticasone propionate at the time points indicated |
| Maximum observed plasma drug concentration (Cmax) for Salmeterol | Samples will be collected at: pre-dose, and 5 minutes (m), 10m, 30m, 45, 1 hour (h), 1.5h, 2h, 4h, 8h, 10h, 12 h, 16h and 24 h post dose in each period | Blood samples will be collected for pharmacokinetic analysis of Salmeterol at the time points indicated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma drug concentration (Cmax) for FP | Samples will be collected at: pre-dose, and 5 minutes (m), 10m, 30m, 45, 1 hour (h), 1.5h, 2h, 4h, 8h, 10h, 12 h, 16h and 24 h post dose in each period | Blood samples will be collected for pharmacokinetic analysis of Fluticasone at the time points indicated |
| Area under the plasma drug concentration versus time curve AUC (0-24h) for Salmeterol | Samples will be collected at: pre-dose, and 5 minutes (m), 10m, 30m, 45, 1 hour (h), 1.5h, 2h, 4h, 8h, 10h, 12 h, 16h and 24 h post dose in each period | Blood samples will be collected for pharmacokinetic analysis of Salmeterol at the time points indicated |
| Time to maximum observed plasma drug concentration (tmax) for FP and Salmeterol | Samples will be collected at: pre-dose, and 5 minutes (m), 10m, 30m, 45, 1 hour (h), 1.5h, 2h, 4h, 8h, 10h, 12 h, 16h and 24 h post dose in each period | Blood samples will be collected for pharmacokinetic analysis of Fluticasone propionate and Salmeterol at the time points indicated |
Countries
United Kingdom
Outcome results
None listed