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Trial record 52 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT02045953
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Asthma Device: VENTOLIN Mini-Spacer Device: Aerochamber Plus spacer Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-Label, Four Period, Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate From FLIXOTIDE™ 250 HFA pMDI and of Fluticasone Propionate and Salmeterol From SERETIDE™ 250/25 HFA pMDI When Given With the VENTOLIN Mini-Spacer Compared to the Aerochamber Plus Spacer in Healthy Subjects
Actual Study Start Date : January 29, 2014
Actual Primary Completion Date : March 13, 2014
Actual Study Completion Date : March 13, 2014


Arm Intervention/treatment
Experimental: Sequence 1
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
VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler

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

Experimental: Sequence 2
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
VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler

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

Experimental: Sequence 3
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
VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler

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

Experimental: Sequence 4
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
VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler

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




Primary Outcome Measures :
  1. Area under the plasma drug concentration versus time curve over 24 hours (AUC[0-24h]) for FP [ Time Frame: 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

  2. Maximum observed plasma drug concentration (Cmax) for Salmeterol [ Time Frame: 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 Outcome Measures :
  1. Maximum observed plasma drug concentration (Cmax) for FP [ Time Frame: 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

  2. Area under the plasma drug concentration versus time curve AUC (0-24h) for Salmeterol [ Time Frame: 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

  3. Time to maximum observed plasma drug concentration (tmax) for FP and Salmeterol [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Exclusion Criteria

  • 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.
  • Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
  • Loss of more than 400 mL of blood during the 3 months before the trial, e.g. as a blood donor.
  • Lactating females.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Unable to refrain from the use of prescription or non-prescription drugs (except simple analgesics), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids from 7 days prior to the first and subsequent doses of study medication and until collection of the last PK sample for that study period.
  • The subject is unable to use the inhaler and spacer devices correctly after training

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045953


Locations
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United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 201092
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02045953     History of Changes
Other Study ID Numbers: 201092
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Healthy Subjects
SERETIDE
Pharmocokinetics
FLIXOTIDE
VENTOLIN Mini-Spacer
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Albuterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents