This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block crossover study to evaluate the effect of single and repeat doses of levocabastine, FF, placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study duration for each individual participating in the study will be a maximum of up to 20 weeks (including the screening and follow-up). This will be a three period study and subjects will be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days between two treatment periods. The rational for this study is to demonstrate proof of concept with the FDC of FF and levocabastine compared with each of the components administered alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
FF/levocabastine (25mcg/50 mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
FF (25mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
levocabastine (50mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
Placebo will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
GSK Investigational Site
Vienna, Austria
Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period
The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
Time frame: Day 8 of each treatment period (up to 80 days)
Weighted Mean of the Magnitude of Symptom Relief on Total Nasal Symptom Score (TNSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period
Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TNSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]).
Time frame: Day 1 of each treatment period (up to 80 days)
Weighted Mean of the Magnitude of Symptom Relief on Total Ocular Symptom Score (TOSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period
Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TOSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\], average of two eyes).
Time frame: Day 1 of each treatment period (up to 80 days)
Weighted Mean of the Total Ocular Symptom Score (TOSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period
The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes , each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\], average of two eyes). TOSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TOSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
Time frame: Day 8 of each treatment period (up to 80 days)
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