Last updated: 11/07/2018 05:37:47
Randomised study comparing the effects of inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) combination and FF on an allergen induced asthmatic response
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline and Day 29 of each treatment period (up to Study Day 197)
Secondary outcomes:
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
Timeframe: Baseline and Day 29 of each treatment period (up to Study Day 197)
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
Timeframe: Baseline and Day 29 of each treatment period (up to Study Day 197)
Number of participants with treatment-emergent adverse events (AEs)
Timeframe: From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)
Interventions:
Drug: Fluticasone Furoate
Drug: FF/Vilanterol (VI; GW642444M)
Drug: Placebo
Enrollment:
52
Observational study model:
Not applicable
Primary completion date:
2010-12-10
Time perspective:
Not applicable
Clinical publications:
Oliver A, Ayer J, Quinn D, Goldfrad C, van Hecke B, Boyce M . Does combined fluticasone furoate / vilanterol reduce the fall in lung function following inhaled allergen 23h after dosing in adult asthma? A randomised, controlled trial. [Clin Transl Allergy]. 2012;2:11.
Oliver A, Ayer J, Quinn D, Goldfrad C, van Hecke B, Boyce M. Does combined fluticasone furoate / vilanterol reduce the fall in lung function following inhaled allergen 23h after dosing in adult asthma? A randomised, controlled trial. Clin Transl Allergy.2012;2(1):11.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
GSK
Study date(s)
January 2010 to October 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
- Females of non-child bearing potential.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Subject is hypertensive at screening
Inclusion and exclusion criteria
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
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
Trial location(s)
Location
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-12-10
Actual study completion date
2010-12-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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