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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/NCT01128569
Registration number
NCT01128569
Ethics application status
Date submitted
20/05/2010
Date registered
24/05/2010
Date last updated
18/01/2017
Titles & IDs
Public title
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
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Scientific title
A Randomised, Double-blind, Placebo-controlled, Three-way Crossover, Repeat Dose Pilot Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination and Fluticasone Furoate on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma
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Secondary ID [1]
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113090
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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
Treatment: Drugs - FF/Vilanterol (VI; GW642444M)
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Placebo Inhaler
Active Comparator: inhaled corticosteroid(ICS)/long acting bronchodilator (LABA) - ICS/LABA inhaler
Active Comparator: ICS - ICS inhaler
Treatment: Drugs: Fluticasone Furoate
FF
Treatment: Drugs: FF/Vilanterol (VI; GW642444M)
FF/VI
Treatment: Drugs: Placebo
Placebo Inhaler
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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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Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
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Assessment method [1]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.
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Timepoint [1]
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Baseline and Day 29 of each treatment period (up to Study Day 197)
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Secondary outcome [1]
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Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
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Assessment method [1]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.
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Timepoint [1]
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Baseline and Day 29 of each treatment period (up to Study Day 197)
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Secondary outcome [2]
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Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
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Assessment method [2]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value
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Timepoint [2]
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Baseline and Day 29 of each treatment period (up to Study Day 197)
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Secondary outcome [3]
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Number of Participants With Treatment-emergent Adverse Events (AEs)
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Assessment method [3]
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The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.
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Timepoint [3]
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From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)
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Eligibility
Key inclusion criteria
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
- Females of non-child bearing potential.
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the
screening visit and currently being treated only with intermittent short-acting beta
-agonist therapy by inhalation
- Pre-bronchodilator FEV1 >70% of predicted at screening
- Subjects who are current non-smokers
- Methacholine challenge PC20 < 8 mg/mL at screening
- Screening allergen challenge demonstrates that the subject experiences an early
asthmatic response
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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
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Subject is hypertensive at screening
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the
first dose of study medication.
- History of life-threatening asthma
- Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
- Unable to abstain from short acting beta agonists
- Unable to abstain from antihistamines
- Unable to abstain from other medications including non-steroidal anti-inflammatory
drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever
medication
- The subject has participated in a study with a new molecular entity during the
previous 3 months or has participated in 4 or more clinical studies in the previous 12
months
- undergoing allergen desensitisation therapy
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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
1/01/2010
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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
1/10/2010
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Berlin
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Country [2]
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New Zealand
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State/province [2]
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Wellington
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Country [3]
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United Kingdom
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State/province [3]
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London
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Country [4]
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United Kingdom
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State/province [4]
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Manchester
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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
We propose to use an inhaled allergen challenge model to explore the individual contributions
of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS)
combination product on protection from allergic triggers in asthma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01128569
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Trial related presentations / publications
Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M. Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Clin Transl Allergy. 2012 Jun 27;2(1):11. doi: 10.1186/2045-7022-2-11.
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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
Name
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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/NCT01128569
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