A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer

NCT02045953 | Completed Phase 1

• 1 other identifier: 201092
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Healthy Subjects; SERETIDE; Pharmocokinetics; FLIXOTIDE; VENTOLIN Mini-Spacer

Outcome Measures

Primary Outcomes (2)

• Area under the plasma drug concentration versus time curve over 24 hours (AUC[0-24h]) for FP

  Blood samples will be collected for pharmacokinetic analysis of Fluticasone propionate at the time points indicated

  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

• Maximum observed plasma drug concentration (Cmax) for Salmeterol

  Blood samples will be collected for pharmacokinetic analysis of Salmeterol at the time points indicated

  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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (4)

Sequence 1

EXPERIMENTAL

Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): ABCD, where A= FLIXOTIDE 250 Hydrofluoroalkane (HFA) with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer

Device: VENTOLIN Mini-Spacer; Device: Aerochamber Plus spacer

Sequence 2

EXPERIMENTAL

Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): BDAC, where A= FLIXOTIDE 250 HFA with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer

Device: VENTOLIN Mini-Spacer; Device: Aerochamber Plus spacer

Sequence 3

EXPERIMENTAL

Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): CADB, where A= FLIXOTIDE 250 HFA with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer

Device: VENTOLIN Mini-Spacer; Device: Aerochamber Plus spacer

Sequence 4

EXPERIMENTAL

Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): DCBA, where A= FLIXOTIDE 250 HFA with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer

Device: VENTOLIN Mini-Spacer; Device: Aerochamber Plus spacer

Interventions

VENTOLIN Mini-Spacer DEVICE

VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Aerochamber Plus spacer DEVICE

Aerochamber Plus spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent.

You may not qualify if:

• 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).
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 milliliter \[mL\]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• Positive smoking breath test or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• A positive pre-study drug/alcohol screen.
• A positive test for human immuno virus antibody.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 201092 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Asthma

Interventions

Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: January 29, 2014
• Primary Completion: March 13, 2014
• Study Completion: March 13, 2014
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)