A Study in Asthmatic Patients to Determine if There is Any Difference in Dosing With Fluticasone Furoate/Vilanterol Inhalation Powder in the Morning or Evening on Lung Function

November 23, 2016 updated by: GlaxoSmithKline

A Randomised, Repeat-dose, Placebo-controlled, Double-blind Study to Evaluate and Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder, When Administered Either in the Morning or in the Evening, in Male and Female Asthmatic Subjects

This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Following screening there will be a run-in period of 14 days. There will be 3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each with a 14-21 day washout period between starting the next. Key assessments include; forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of AM and PM dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder(100/25mcg) on lung function. Twenty-four male and female patients will be enrolled in this study to ensure twenty evaluable subjects. After the screening there will be a run-in period of 14 days prior to first dose. Subjects will be dosed for 14 days (± 2 days) in each of the 3 treatment periods, with serial forced expiratory volume in one second (FEV1) measurements taken over a 24 hour period following the Day 14 PM dose in order to determine FEV1 weighted mean (0-24 hours). Peak expiratory flow (PEF) will also be monitored throughout the study, from the start of the run-in period until the end of the third treatment period. Between treatment periods there will be a washout period of 14-21 days. Safety assessments will include vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests, however, with the exception of AEs these will not constitute study endpoints. The results of the study will provide supporting information to understand the implications of time of day of dosing on the therapeutic response to the FF/VI Inhalation Powder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • New Zealand
      • Wellington, New Zealand, 6021
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases.
  • Male or female between 18 and 70 years of age inclusive

  • A female subject is eligible to participate if she is of:

    • Non-childbearing potential. 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 postmenopausal status prior to study enrollment.
    • Child-bearing potential and agrees to use one of the protocol contraception methods.
  • All subjects must be using an inhaled corticosteroid (ICS), with or without a short-acting, beta2-receptor agonist (SABA), for at least 12 weeks prior to screening.
  • Subjects with a screening pre-bronchodilator FEV1 ≥ 60% of predicted.
  • During the screening visit, subjects must demonstrate the presence of reversible airway disease.
  • All subjects must be able to replace all their current asthma treatments with albuterol/salbutamol aerosol inhaler at screening for use as needed for the run-in period and throughout the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits.
  • Subjects who are current non-smokers, who have not used any inhaled tobacco products in the 12 month period preceding the screening visit.
  • Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19.0-29.9 kg/m2 (inclusive).
  • No evidence of significant abnormality in the 12-lead ECG performed at screening.
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2x Upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Capable of giving written informed consent
  • Able to satisfactorily use the novel dry powder inhaler.

Exclusion Criteria:

  • A history of life-threatening asthma within the last 5 years.
  • Culture-documented or suspected bacterial or viral infection that is not resolved within 4 weeks of screening and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
  • A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation.
  • A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening.
  • Pregnant females.
  • Lactating females.
  • The subject has participated in a clinical trial and has received an investigational product within 30 days prior to the first dosing day in the current study.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Any adverse reaction including immediate or delayed hypersensitivity to any beta 2- agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy.
  • History of severe milk protein allergy.
  • History of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Use of prescription or non-prescription drugs 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.
  • Subjects who have taken high doses of an ICS within 8 weeks of the screening visit or oral steroids within 12 weeks of the screening visit.
  • Subjects who have changed their ICS treatment within the last 4 weeks before screening or can be expected to do so during the study.
  • History of regular alcohol consumption within 6 months of the study.
  • A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
  • A positive breath carbon monoxide (CO) test.
  • A positive pre-study drug/alcohol screen.
  • A positive test for Human Immunodeficiency Virus (HIV) antibody.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • No subject is permitted to perform night shift work for 1 week prior to screening until completion of the study treatment periods.
  • Unwillingness or inability to follow the procedures outlined in the protocol.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FF(100mcg)/Vilanterol(25mcg) - AM dosing
FF(100mcg)/Vilanterol(25mcg) in the morning (approx 09.00) for 14 days (± 2 days).; placebo in evening (approx 21.00) for 14 days (± 2 days).
Drug: FF(100mcg)/Vilanterol(25mcg) AM
Inhalation powder
Drug: Placebo PM
Inhalation powder
Experimental: FF(100mcg)/Vilanterol(25mcg) - PM dosing
Placebo in morning (approx 09.00) for 14 days (± 2 days); FF(100mcg)/Vilanterol(25mcg) in evening (approx 21.00) for 14 days (± 2 days).
Drug: FF(100mcg)/Vilanterol(25mcg) PM
Inhalation powder
Drug: Placebo AM
Inhalation powder
Placebo Comparator: Placebo
Placebo given in morning (approx 09.00) and in evening (approx (21.00) for 14 days (± 2 days).
Drug: Placebo PM
Inhalation powder
Drug: Placebo AM
Inhalation powder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0-24 Hours Post-dose on Day 14
Time Frame: Pre-dose on Day 14 to 24 hours post-dose
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).
Pre-dose on Day 14 to 24 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre-treatment PEF (AM and PM) on Days 1-12.
Time Frame: From Day 2 up to Day 12
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 2 to 12 was analyzed. The analysis was performed using a mixed effect analysis of covariance model with fixed effect terms for treatment and period; baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=26). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=24).
From Day 2 up to Day 12
AM and PM Pre-treatment Trough FEV1 on Day 14
Time Frame: Day 14
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Trough FEV1 is defined as pre-dose (AM and PM) FEV1 measurement taken on Day 14. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant baseline, period baseline, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=23).
Day 14
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Time Frame: From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN) and total bilirubin >=2 x ULN or international normalised ratio >1.5. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs and SAEs.
From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

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.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 114624

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

  1. Statistical Analysis Plan
    Information identifier: 114624
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: 114624
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 114624
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 114624
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 114624
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 114624
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 114624
    Information 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.

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