Phase 2
Completed N=52
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
Source: ClinicalTrials.gov NCT01128569 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: 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 — -0.372; -0.210; -0.227 Liters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-0.372; -0.210; -0.227 | — |
| SECONDARY 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 |
-24.991; -14.040; -13.206 | — |
| SECONDARY 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 |
-0.809; -0.479; -0.478 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
20; 22; 18 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01128569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.