Trial Outcomes & Findings for 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) (NCT NCT01957202)
NCT ID: NCT01957202
Last Updated: 2017-01-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Day 8 of each treatment period (up to 80 days)
Results posted on
2017-01-09
Participant Flow
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.
Participant milestones
| Measure |
Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo
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.
|
Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
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.
|
Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
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.
|
Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
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.
|
Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
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.
|
Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
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.
|
Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
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.
|
Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
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.
|
Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
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.
|
Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
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.
|
Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
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.
|
Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
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.
|
Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
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.
|
Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (8 Days)
STARTED
|
3
|
6
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
6
|
3
|
|
Treatment Period 1 (8 Days)
COMPLETED
|
3
|
6
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
6
|
3
|
|
Treatment Period 1 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
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
|
|
Washout Period 1 (14 to 28 Days)
COMPLETED
|
3
|
6
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
6
|
3
|
|
Washout Period 1 (14 to 28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (8 Days)
STARTED
|
3
|
6
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
6
|
3
|
|
Treatment Period 2 (8 Days)
COMPLETED
|
3
|
5
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
5
|
3
|
|
Treatment Period 2 (8 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
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
|
|
Washout Period 2 (14 to 28 Days)
COMPLETED
|
3
|
5
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
5
|
3
|
|
Washout Period 2 (14 to 28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (8 Days)
STARTED
|
3
|
5
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
5
|
3
|
|
Treatment Period 3 (8 Days)
COMPLETED
|
3
|
5
|
6
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
3
|
6
|
3
|
4
|
3
|
|
Treatment Period 3 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo
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.
|
Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
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.
|
Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
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.
|
Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
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.
|
Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
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.
|
Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
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.
|
Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
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.
|
Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
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.
|
Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
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.
|
Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
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.
|
Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
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.
|
Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
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.
|
Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
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.
|
Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
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.
|
Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 2 (8 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 3 (8 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo
n=71 Participants
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.
|
|---|---|
|
Age, Continuous
|
29.4 Years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
|
Gender
Female
|
36 Participants
n=5 Participants
|
|
Gender
Male
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8 of each treatment period (up to 80 days)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
|
FF 100 μg
n=54 Participants
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
|
Levo 200 μg
n=53 Participants
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
|
FF 100 μg/Levo 200 μg
n=66 Participants
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
|
|---|---|---|---|---|
|
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
|
6.030 Scores on a scale
Interval 5.35 to 6.71
|
4.189 Scores on a scale
Interval 3.646 to 4.731
|
4.500 Scores on a scale
Interval 3.955 to 5.044
|
1.933 Scores on a scale
Interval 1.438 to 2.428
|
SECONDARY outcome
Timeframe: Day 1 of each treatment period (up to 80 days)Population: PD Population
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 \[0=none, 1=mild, 2=moderate, 3=severe\]).
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
|
FF 100 μg
n=54 Participants
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
|
Levo 200 μg
n=53 Participants
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
|
FF 100 μg/Levo 200 μg
n=68 Participants
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
|
|---|---|---|---|---|
|
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
|
-1.335 Scores on a scale
Interval -1.861 to -0.81
|
-0.904 Scores on a scale
Interval -1.332 to -0.476
|
-2.588 Scores on a scale
Interval -3.018 to -2.157
|
-2.267 Scores on a scale
Interval -2.658 to -1.877
|
SECONDARY outcome
Timeframe: Day 1 of each treatment period (up to 80 days)Population: PD Population
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).
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
|
FF 100 μg
n=54 Participants
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
|
Levo 200 μg
n=53 Participants
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
|
FF 100 μg/Levo 200 μg
n=68 Participants
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
|
|---|---|---|---|---|
|
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
|
-0.097 Scores on a scale
Interval -0.431 to 0.237
|
-0.272 Scores on a scale
Interval -0.537 to -0.007
|
-0.633 Scores on a scale
Interval -0.901 to -0.365
|
-0.446 Scores on a scale
Interval -0.683 to -0.209
|
SECONDARY outcome
Timeframe: Day 8 of each treatment period (up to 80 days)Population: PD Population. Only those participants contributing data at the indicated time points were analyzed.
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.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
|
FF 100 μg
n=54 Participants
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
|
Levo 200 μg
n=53 Participants
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
|
FF 100 μg/Levo 200 μg
n=66 Participants
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
|
|---|---|---|---|---|
|
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
|
1.321 Scores on a scale
Interval 0.97 to 1.673
|
0.761 Scores on a scale
Interval 0.465 to 1.057
|
0.621 Scores on a scale
Interval 0.323 to 0.919
|
0.546 Scores on a scale
Interval 0.268 to 0.824
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FF 100 μg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Levo 200 μg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
FF 100 μg/Levo 200 μg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
|
FF 100 μg
n=54 participants at risk
Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
|
Levo 200 μg
n=53 participants at risk
Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
|
FF 100 μg/Levo 200 μg
n=68 participants at risk
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
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.9%
2/34 • 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).
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.
|
1.9%
1/54 • 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).
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.
|
1.9%
1/53 • 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).
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.
|
1.5%
1/68 • 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).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • 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).
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.
|
0.00%
0/54 • 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).
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.
|
0.00%
0/53 • 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).
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.
|
1.5%
1/68 • 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).
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.
|
|
General disorders
Fatigue
|
2.9%
1/34 • 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).
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.
|
0.00%
0/54 • 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).
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.
|
0.00%
0/53 • 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).
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.
|
1.5%
1/68 • 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).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/34 • 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).
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.
|
0.00%
0/54 • 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).
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.
|
0.00%
0/53 • 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).
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.
|
1.5%
1/68 • 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).
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER