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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01287065




Registration number
NCT01287065
Ethics application status
Date submitted
27/01/2011
Date registered
1/02/2011
Date last updated
11/01/2017

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
114624
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FF(100mcg)/Vilanterol(25mcg) AM
Treatment: Drugs - FF(100mcg)/Vilanterol(25mcg) PM
Treatment: Drugs - Placebo AM
Treatment: Drugs - Placebo PM

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).

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).

Placebo Comparator: Placebo - Placebo given in morning (approx 09.00) and in evening (approx (21.00) for 14 days (± 2 days).


Treatment: Drugs: FF(100mcg)/Vilanterol(25mcg) AM
Inhalation powder

Treatment: Drugs: FF(100mcg)/Vilanterol(25mcg) PM
Inhalation powder

Treatment: Drugs: Placebo AM
Inhalation powder

Treatment: Drugs: Placebo PM
Inhalation powder
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0-24 Hours Post-dose on Day 14
Timepoint [1] 0 0
Pre-dose on Day 14 to 24 hours post-dose
Secondary outcome [1] 0 0
Pre-treatment PEF (AM and PM) on Days 1-12.
Timepoint [1] 0 0
From Day 2 up to Day 12
Secondary outcome [2] 0 0
AM and PM Pre-treatment Trough FEV1 on Day 14
Timepoint [2] 0 0
Day 14
Secondary outcome [3] 0 0
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Timepoint [3] 0 0
From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01287065
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries