Last updated: 11/07/2018 05:41:40
Randomised study comparing the effects of inhaled FF/GW642444M combination, FF and GW642444M 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, four-way crossover, repeat dose study comparing the effect of inhaled fluticasone furoate/GW642444M combination, GW642444M and fluticasone furoate on the allergen-induced 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/ inhaled corticosteroid combination product and its components on protection from allergic triggers in asthma
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Late Asthmatic Response (LAR): absolute change from saline in minimum FEV1 between 4-10 hours (hrs) following the 1-hr post-treatment allergen challenge on Day 21 of each treatment period
Timeframe: Day 21 of each treatment period (up to Study Day 197)
LAR: absolute change from saline in weighted mean (WM) FEV1 between 4-10 hrs following the 1-hr post-treatment allergen challenge on Day 21 of each treatment period
Timeframe: Day 21 of each treatment period (up to Study Day 197)
Early Asthmatic Response (EAR): absolute change from saline in minimum FEV1 between 0-2 hrs following the 1-hr post-treatment allergen challenge on Day 21 of each treatment period
Timeframe: Day 21 of each treatment period (up to Study Day 197)
EAR: absolute change from saline in weighted mean FEV1 between 0-2 hrs following the 1-hr post-treatment allergen challenge on Day 21 of each treatment period
Timeframe: Day 21 of each treatment period (up to Study Day 197)
Secondary outcomes:
Maximum percent change from saline in FEV1 between 0-2 hrs, following the 1-hr post-treatment allergen challenge on Day 21 of each treatment period
Timeframe: Day 21 of each treatment period (up to Study Day 197)
Provocative concentration of methacholine estimated to result in a 20% reduction in FEV1 (PC20) on Day 22 of each treatment period
Timeframe: Day 22 of each treatment period (up to Study Day 198)
Interventions:
Drug: FF/GW642444M
Drug: GW642444M
Drug: Fluticasone Furoate
Drug: Placebo
Enrollment:
27
Observational study model:
Not applicable
Primary completion date:
2011-31-05
Time perspective:
Not applicable
Clinical publications:
Oliver A, Bjermer L, Quinn D, Saggu P, Thomas P, Yarnall K, Lötvall J. Modulation of allergen-induced bronchoconstriction by fluticasone furoate and vilanterol alone or in combination. Allergy. 2013;68(9):1136-42.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
GSK
Study date(s)
May 2010 to May 2011
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:
- 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
Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
Exclusion criteria:
- 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
Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Trial location(s)
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
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
2011-31-05
Actual study completion date
2011-31-05
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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