- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213849
Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler
June 13, 2017 updated by: GlaxoSmithKline
An Open-label, Randomised, 3-way Crossover Single Dose Study to Demonstrate Dose Proportionality of Fluticasone Furoate (FF) and Equivalence of Vilanterol (VI) When Administered as FF/VI Inhalation Powder From the Novel Dry Powder Inhaler in Healthy Subjects.
The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will be an open-label, randomised, 3-way cross-over single dose study in 24 healthy subjects to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) following single dose administration of FF/VI via the novel dry powder inhaler.
In each of 3 treatment periods, subjects will receive 4 inhalations of 50/25 mcg, 100/25 mcg, 200/25 mcg FF/VI.
Blood samples will be taken for pharmacokinetic analysis and safety (12-lead ECGs, clinical laboratory test, vital signs, adverse events) will be monitored following each dose.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, NW10 7EW
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <or= 1.5xULN
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
Non-child-bearing potential defined as post-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea.
Child-bearing potential and agrees to use one of the approved contraception methods until 16 weeks after the last dose.
- Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods until 16 weeks after the last dose.
- Body Mass Index (BMI) within range 18.5-29.0 kg/m2 (inclusive).
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTcF < 450 msec.
- No clinically significant abnormality on the Holter electrocardiogram (ECG) at screening.
- Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of < or = 5 pack years.
- Able to satisfactorily use the dry powder inhaler.
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (forced expiratory volume in 1 minute (FEV1)) will be performed to confirm normal lung function parameters (>or=85% predicted).
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- A positive HIV antibody.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- History of heavy 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.
- History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening.
- Positive carbon monoxide or alcohol breath test at screening or on admission to the unit.
- A positive pre-study urine drug screen or when randomly tested during the study.
- 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: 3 months, 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.
- Use of prescription or non-prescription drugs, 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.
- The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit.
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
- History of sensitivity or adverse reaction to any of the study medications including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or an intranasal, inhaled or systemic corticosteroid; known suspected sensitivity to the constituents of the new powder inhaler (lactose or magnesium stearate) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation.
- History of severe milk protein allergy.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months of the start of the study.
- Pregnant females as determined by positive serum hCG test at screening or by positive serum/urine hCG test prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 200/100 mcg fluticasone furoate/vilanterol
4 inhalations of 50/25 mcg fluticasone furoate/vilanterol
|
4 inhalations of 50 mcg strength
4 inhalations of 25 mcg strength
|
Experimental: 400/100 mcg fluticasone furoate/vilanterol
4 inhalations of 100/25 mcg fluticasone furoate/vilanterol
|
4 inhalations of 25 mcg strength
4 inhalations of 100 mcg strength
|
Experimental: 800/100 mcg fluticasone furoate/vilanterol
4 inhalations of 200/25 mcg fluticasone furoate/vilanterol
|
4 inhalations of 200 mcg strength
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fluticasone furoate area under concentration-time curve (AUC)
Time Frame: 48 hours post-dose
|
48 hours post-dose
|
Fluticasone furoate maximum observed concentration (Cmax)
Time Frame: 48 hours post-dose
|
48 hours post-dose
|
Vilanterol area under concentration-time curve (AUC)
Time Frame: 48 hours post-dose
|
48 hours post-dose
|
Vilanterol maximum observed concentration (Cmax)
Time Frame: 48 hours post-dose
|
48 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fluticasone furoate time of occurence of maximum concentration (tmax)
Time Frame: 48 hours post-dose
|
48 hours post-dose
|
Vilanterol time of occurence of maximum concentration (tmax)
Time Frame: 48 hours post-dose
|
48 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2010
Primary Completion (Actual)
November 25, 2010
Study Completion (Actual)
November 25, 2010
Study Registration Dates
First Submitted
October 1, 2010
First Submitted That Met QC Criteria
October 1, 2010
First Posted (Estimate)
October 4, 2010
Study Record Updates
Last Update Posted (Actual)
June 14, 2017
Last Update Submitted That Met QC Criteria
June 13, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102932
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
Study Data/Documents
-
Study Protocol
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 102932Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Fluticasone furoate 50 mcg (4 inhalations)
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Germany, Romania, Russian Federation, Ukraine, Chile, Sweden, Mexico, Netherlands, Poland
-
SandozCompletedRhinitis, Allergic, SeasonalUnited States
-
Amneal Pharmaceuticals, LLCNovum Pharmaceutical Research ServicesCompleted
-
SandozCompletedRhinitis, Allergic, SeasonalUnited States
-
Organon and CoCompleted
-
Neutec Ar-Ge San ve Tic A.ŞWithdrawn
-
GlaxoSmithKlineWithdrawnPulmonary Disease, Chronic ObstructiveCanada, Germany
-
GlaxoSmithKlineCompleted