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A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR)

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ClinicalTrials.gov Identifier: NCT01957202
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : October 8, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rhinitis, Allergic, Perennial and Seasonal
Interventions Drug: FF/levocabastine
Drug: FF
Drug: levocabastine
Drug: Placebo
Enrollment 71
Recruitment Details  
Pre-assignment Details Participants who met the eligibility criteria at Screening were randomized to 1 of 18 treatment sequences. The treatment phase was comprised of three 8-day treatment periods, each separated by a 14- to 28-day washout period.
Arm/Group Title Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
Hide Arm/Group Description Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 μg/Levo 200 μg, placeboμg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo µg OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days. Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Period Title: Treatment Period 1 (8 Days)
Started 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Completed 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 1 (14 to 28 Days)
Started 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Completed 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Treatment Period 2 (8 Days)
Started 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Completed 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3
Not Completed 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Period Title: Washout Period 2 (14 to 28 Days)
Started 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3
Completed 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Treatment Period 3 (8 Days)
Started 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3
Completed 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 4 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Arm/Group Title FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo
Hide Arm/Group Description Participants received FF 100 µg, Levo 200 µg, FF 100 μg/Levo 200 μg and placebo once daily (OD) in the morning as 2 nasal sprays (FF: 25 µg per spray, Levo: 50 μg per spray, FF/Levo: 25 μg/50 μg per spray) into each nostril for 8 days each, in a crossover design. Treatment was given in one of 18 sequences in Periods 1, 2, and 3, (with a minimum of a 14-day washout period between treatments): BCD, BAC, BCA, DAC, DCB, CDB, ADC, CAD, DCA, ACB, BDC, CBA, CBD, ACD, CAB, CDA, ABC, DBC (A, FF 100 μg; B, Levo 200 μg; C, FF 100 μg/Levo 200 μg; D, placebo). On Day 1 and Day 8 of each treatment period, participants were subjected to an allergen challenge in a Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit of 14-28 days after their last dose, and the overall duration for participation in the study (screening to follow-up) was 20 weeks.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants
29.4  (8.91)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
36
  50.7%
Male
35
  49.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants
Asian - East Asian Heritage 2
White - White/Caucasian/European Heritage 69
1.Primary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of investigational product) and who also provided data from at least one PD assessment. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Hide Arm/Group Description:
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
Overall Number of Participants Analyzed 34 54 53 66
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
6.030
(5.350 to 6.710)
4.189
(3.646 to 4.731)
4.500
(3.955 to 5.044)
1.933
(1.438 to 2.428)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF 100 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.255
Confidence Interval (2-Sided) 95%
-2.895 to -1.616
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Levo 200 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.566
Confidence Interval (2-Sided) 95%
-3.208 to -1.925
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.531
Confidence Interval (2-Sided) 95%
-2.342 to -0.719
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.842
Confidence Interval (2-Sided) 95%
-2.654 to -1.029
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.097
Confidence Interval (2-Sided) 95%
-4.857 to -3.337
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection FF 100 μg, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3699
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.311
Confidence Interval (2-Sided) 95%
-0.994 to 0.372
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population
Arm/Group Title Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Hide Arm/Group Description:
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
Overall Number of Participants Analyzed 34 54 53 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-1.335
(-1.861 to -0.810)
-0.904
(-1.332 to -0.476)
-2.588
(-3.018 to -2.157)
-2.267
(-2.658 to -1.877)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF 100 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.364
Confidence Interval (2-Sided) 95%
-1.853 to -0.874
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Levo 200 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1975
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.320
Confidence Interval (2-Sided) 95%
-0.169 to 0.809
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.252
Confidence Interval (2-Sided) 95%
-1.870 to -0.635
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1648
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.432
Confidence Interval (2-Sided) 95%
-0.179 to 1.042
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.932
Confidence Interval (2-Sided) 95%
-1.506 to -0.358
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection FF 100 μg, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.684
Confidence Interval (2-Sided) 95%
1.160 to 2.208
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population
Arm/Group Title Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Hide Arm/Group Description:
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
Overall Number of Participants Analyzed 34 54 53 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.097
(-0.431 to 0.237)
-0.272
(-0.537 to -0.007)
-0.633
(-0.901 to -0.365)
-0.446
(-0.683 to -0.209)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF 100 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3052
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.174
Confidence Interval (2-Sided) 95%
-0.508 to 0.160
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Levo 200 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2725
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.187
Confidence Interval (2-Sided) 95%
-0.149 to 0.523
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0118
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.536
Confidence Interval (2-Sided) 95%
-0.952 to -0.120
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4049
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.175
Confidence Interval (2-Sided) 95%
-0.588 to 0.239
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0793
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.349
Confidence Interval (2-Sided) 95%
-0.739 to 0.041
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection FF 100 μg, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0478
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.361
Confidence Interval (2-Sided) 95%
0.004 to 0.719
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Hide Arm/Group Description:
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
Overall Number of Participants Analyzed 34 54 53 66
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
1.321
(0.970 to 1.673)
0.761
(0.465 to 1.057)
0.621
(0.323 to 0.919)
0.546
(0.268 to 0.824)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF 100 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1502
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.215
Confidence Interval (2-Sided) 95%
-0.509 to 0.079
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Levo 200 μg, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6177
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.075
Confidence Interval (2-Sided) 95%
-0.370 to 0.221
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.701
Confidence Interval (2-Sided) 95%
-1.080 to -0.322
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.560
Confidence Interval (2-Sided) 95%
-0.934 to -0.187
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, FF 100 μg/Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.775
Confidence Interval (2-Sided) 95%
-1.123 to -0.428
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection FF 100 μg, Levo 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3807
Comments [Not Specified]
Method Mixed Model ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.140
Confidence Interval (2-Sided) 95%
-0.175 to 0.456
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the All Subject Population, comprised of all all participants who receive at least one dose of Investigational product.
 
Arm/Group Title Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Hide Arm/Group Description Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
All-Cause Mortality
Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/54 (0.00%)   0/53 (0.00%)   0/68 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo FF 100 μg Levo 200 μg FF 100 μg/Levo 200 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/34 (5.88%)   1/54 (1.85%)   1/53 (1.89%)   3/68 (4.41%) 
Gastrointestinal disorders         
Diarrhoea  1  0/34 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  1/68 (1.47%) 
General disorders         
Fatigue  1  1/34 (2.94%)  0/54 (0.00%)  0/53 (0.00%)  1/68 (1.47%) 
Nervous system disorders         
Headache  1  2/34 (5.88%)  1/54 (1.85%)  1/53 (1.89%)  1/68 (1.47%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/34 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  1/68 (1.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01957202     History of Changes
Other Study ID Numbers: 200286
First Submitted: October 4, 2013
First Posted: October 8, 2013
Results First Submitted: October 2, 2014
Results First Posted: October 8, 2014
Last Update Posted: January 9, 2017