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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/NCT02712047
Registration number
NCT02712047
Ethics application status
Date submitted
14/03/2016
Date registered
17/03/2016
Date last updated
28/08/2018
Titles & IDs
Public title
A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.
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Scientific title
A Randomised, Placebo-controlled, Double-blind, Two Period Crossover Study to Characterise the Exhaled Nitric Oxide Time Profile as a Biomarker of Airway Inflammation in Adult Asthma Patients Following Repeat Administration of Inhaled Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 mcg.
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Secondary ID [1]
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201499
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fluticasone furoate (FF) (100 mcg)
Treatment: Drugs - Vilanterol (VI) (25 mcg)
Treatment: Drugs - Placebo
Experimental: Fluticasone furoate/vilanterol (FF/VI) 100/25 mcg - Subjects will receive FF/VI 100/25 mcg each morning (once daily) from Day 1 to Day 14, followed by a 21-day monitoring/washout period
Placebo Comparator: Placebo - Subjects will receive placebo each morning (once daily) from Day 1 to Day 14, followed by a 21-day monitoring/washout period
Treatment: Drugs: Fluticasone furoate (FF) (100 mcg)
First blister strip contains FF blended with lactose, 100 mcg per blister
Treatment: Drugs: Vilanterol (VI) (25 mcg)
Second blister strip contains vilanterol blended with lactose and magnesium stearate, 25 mcg per blister
Treatment: Drugs: Placebo
Matching placebo will have two blister strips, identical in appearance to the inhaler containing active study medication; one containing lactose and the second strip containing lactose and magnesium stearate
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI
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Assessment method [1]
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FeNO is non-invasive marker of airway inflammation in asthma participants. It was measured by the participants, using Niox Vero device at AM (pre-dose) and PM on Day -7 and all way through Day 29 of each TP. The FeNO measurements were done over time following stop of repeat dose treatment with FF/VI. Change from Baseline was measured as ratio of post-dose visit value to Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline defined as the mean of Baseline across periods for each participant. Period level Baseline defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Summary of ratio from Baseline for exhaled nitric oxide reported as Geometric mean and Geometric coefficient of Variation. NA indicates data was not available.
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Timepoint [1]
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Baseline and up to Day 29 in each treatment period
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Secondary outcome [1]
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Change From Baseline in FeNO Over the FF/VI Treatment Period
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Assessment method [1]
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In participants with asthma the FeNO is a non-invasive marker of airway inflammation. The FeNO was measured by the participants AM (pre-dose) and PM on Day -7 and all the way through Day 29 of each treatment period. The measurements were recorded using Niox Vero device provided at the site. These FeNO measurements were done throughout the treatment period. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
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Timepoint [1]
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Baseline and up to Day 29 in each treatment period
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Secondary outcome [2]
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Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI
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Assessment method [2]
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The PEF is a lung function evaluation assessed using a PEF meter. It was defined as the maximum amount of air exhaled during forced exhalation with lungs fully inflated. For PEF measurements the best of the 3 recordings were recorded AM and PM (i.e every 12 hours), from Day-7 through to Day 29 of TP1, and then from Day 1 of TP2 through to the (29). Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
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Timepoint [2]
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Baseline and up to Day 29 in TP1; Baseline and up to follow up (Day 29) in TP2
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Secondary outcome [3]
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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI
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Assessment method [3]
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FEV1 is defined as the maximal amount of air which can be exhaled forcefully in one second. Three technically acceptable FEV1 measurements were made using a spirometer, and were measured on pre-dose on Day 1, taken pre-dose on Day 14 and every morning and evening until Day 19, and in the morning on Day 21. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant.
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Timepoint [3]
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Baseline every morning and evening until Day 21 of each treatment period
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Eligibility
Key inclusion criteria
- Age of subject: Between 18 and 65 years of age inclusive, at the time of signing the
informed consent.
- A doctor diagnosis of asthma for at least 6 months prior to the start of the study.
- Severity of disease: A screening pre-bronchodilator forced expiratory volume in one
second (FEV1) >=60% of predicted values, which will be based upon NHANES III
- Reversibility of disease: Demonstrated presence of reversible airway disease at
screening (repeat testing of eligibility can be undertaken following the screening
visit up to Day -7) OR The presence of reversible airways disease can have been
demonstrated historically within 6 months of the screening visit. Reversible airway
disease is defined as increase in FEV1 of >=12% over baseline and an absolute change
of >=200 mL within 30 minutes following 4 inhalations of albuterol/salbutamol
inhalation aerosol/spacer (or equivalent nebulised treatment with albuterol/salbutamol
solution).
- Current Therapy: Short-acting beta2-agonists (SABA) prescribed for at least 12 weeks
prior to screening. No inhaled corticosteroids (ICS), long-actint beta2-receptor
agonist (LABA), long acting muscarinic anatagonist (LAMA), leukotriene receptor
antagonist (LTRA) therapy for three months prior to the start of the study.
- Non-smoker or ex-smoker (no smoking in previous 12 weeks, =10 pack years).
- Screening and Day -7 AM fraction of inhaled nitric oxide (FeNO) values > 40ppb. Both
screening and Day -7 AM FeNO values for treatment Period 1 need to be > 40ppb for the
subject to be eligible.
- Bodyweight and BMI: Bodyweight >=50 kg and body mass index (BMI) within the range 18.0
40.0 kg/m2 (inclusive)
- Male OR Female:
- Females: A female subject is eligible to participate if she is not pregnant (as
confirmed by a negative urine human chorionic gonadotrophin [hCG[ test), not
lactating, and at least one of the following conditions applies: Non-reproductive
potential defined as:
- Pre-menopausal females reporting one of the following:
Tubal ligation Hysteroscopic tubal occlusion procedure with follow-up confirmation of
bilateral tubal occlusion Hysterectomy Bilateral Oophorectomy
- Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a
blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels
consistent with menopause [refer to laboratory reference ranges for confirmatory
levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is
in doubt will be required to use one of the highly effective 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 enrolment.
- Reproductive potential and agrees to follow one of the options listed in the Modified
List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive
Potential (FRP) from 30 days prior to the first dose of study medication and until
after the last dose of study medication and completion of the follow-up visit
- The investigator is responsible for ensuring that subjects understand how to properly
use these methods of contraception.
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the consent form and in this protocol.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- A history of life-threatening asthma, which is defined as an asthma episode that
required intubation and/or was associated with hypercapnia, respiratory arrest or
hypoxic seizures within the last 5 years
- Other significant pulmonary diseases to include (but not limited to): pneumonia,
pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia,
chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other
respiratory abnormalities other than asthma.
- Respiratory Infection: Culture-documented or suspected bacterial or viral infection of
the upper or lower respiratory tract, sinus or middle ear that is not resolved within
4 weeks of screening that 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. However, subjects can be rescreened to allow for
an adequate time period (of at least 4 weeks) between resolution of the infection and
the date of randomisation.
- Asthma Exacerbation: 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.
- Pre-defined concomitant medications and restrictions of nitrate-rich foods
- Tobacco Use: Current smokers or a smoking history of >=10 pack years. A subject may
not have used any inhaled tobacco products in 12 weeks preceding the screening visit.
- Previous Participation: Exposure to more than four new chemical entities within 12
months prior to the first dosing day.
- Other concurrent Diseases/Abnormalities: 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 or would
confound the interpretation of the study results if the condition/disease exacerbated
during the study.
- The list of additional excluded conditions/diseases includes, but is not limited to
the following:
- Congestive heart failure-Known aortic aneurysm
- Clinically significant coronary heart disease-Clinically significant cardiac
arrhythmia
- Stroke within 3 months of Visit 1-Uncontrolled hypertension
- Recent or poorly controlled peptic ulcer-Haematologic, hepatic, or renal disease
- Immunologic compromise-Current malignancy
- Tuberculosis (current or untreated)-Cushing's disease
- Addison's disease-Uncontrolled diabetes mellitus
- Liver cirrhosis-Systemic Lupus Erythematosus
- Uncontrolled thyroid disorder-Recent history of drug or alcohol abuse
- Oropharyngeal examination: A subject will not be eligible if he/she has clinical
visual evidence of oral candidiasis at screening.
- Pregnancy and Lactating Females:
- Pregnant females as determined by positive serum hCG test at screening or by positive
urine hCG test prior to dosing.
- Lactating females
- Allergies:
- Milk Protein Allergy: History of severe milk protein allergy.
- Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to
any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic
corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry
Powder Inhaler (DPI) (i.e., lactose or magnesium stearate).
- Historical Allergy: History of drug or other allergy that, in the opinion of
investigator or GSK Medical Monitor, contraindicates their participation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/02/2017
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Sample size
Target
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Accrual to date
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Final
28
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Newtown, Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2
receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric
oxide (FeNO) is a non-invasive airway inflammation marker.
In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose
study, the duration of action of fluticasone furoate (FF) will be determined by monitoring
the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in
asthmatic subjects.
Subjects who meet the eligibility criteria will participate in the following two treatment
periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will
be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be
followed by a 21-day monitoring/washout period before crossing over to the next treatment
period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored
up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02712047
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02712047
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