Trial Outcomes & Findings for Intranasal SB-705498 in Allergic Rhinitis (AR) Patients (NCT NCT01424397)

NCT ID: NCT01424397

Last Updated: 2019-09-13

Results Overview

Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Weighted mean (WM) of TNSS and its individual components (nasal congestion, rhinorrhoea, itching and sneezing) are presented on Day 8. Weighted mean was calculated over the time interval 0 to 4 hours after start of allergen chamber challenge by calculating the area under the curve of TNSS/component from time of the first observation to time of the last observation (AUC \[tf-t1 hours\]) using the trapezoidal rule, and then dividing by the actual relevant time interval (tf-t1) required by participant to complete the chamber challenge assessments. A Bayesian analysis was conducted to derive the posterior probability for TNSS.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Day 8 of each treatment period
• Results posted on: 2019-09-13

Participant Flow

A total of 70 male and female participants with a history of allergic rhinitis (AR) were enrolled in this study. Study period was 14 April 2011 to 07 July 2011.

There were 3 study treatment periods each lasting 8 days separated by a washout of 14-20 days. Participants were randomized to 12 different sequences.

Participant milestones

Measure	Treatment A First, Then B, Then D Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B First, Then A, Then D Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then D, Then A Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then D, Then B Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment D, Then A, Then B Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment D, Then B, Then A Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then B, Then C Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then A, Then C Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then C, Then A Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then C, Then B Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment C, Then A, Then B Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment C, Then B, Then A Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
Period-1 (8 Days) STARTED	7	8	8	8	8	8	4	4	4	3	4	4
Period-1 (8 Days) COMPLETED	7	8	8	8	8	8	4	4	4	3	4	4
Period-1 (8 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Washout Period-1 (14-20 Days) STARTED	7	8	8	8	8	8	4	4	4	3	4	4
Washout Period-1 (14-20 Days) COMPLETED	7	8	8	8	8	8	4	4	4	3	4	4
Washout Period-1 (14-20 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period-2 (8 Days) STARTED	7	8	8	8	8	8	4	4	4	3	4	4
Period-2 (8 Days) COMPLETED	7	8	7	8	8	8	4	4	4	3	4	4
Period-2 (8 Days) NOT COMPLETED	0	0	1	0	0	0	0	0	0	0	0	0
Washout Period-2 (14-20 Days) STARTED	7	8	7	8	8	8	4	4	4	3	4	4
Washout Period-2 (14-20 Days) COMPLETED	7	8	7	8	8	8	4	4	4	3	4	4
Washout Period-2 (14-20 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period-3 (8 Days) STARTED	7	8	7	8	8	8	4	4	4	3	4	4
Period-3 (8 Days) COMPLETED	7	8	7	8	8	8	4	4	4	3	4	4
Period-3 (8 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Treatment A First, Then B, Then D Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B First, Then A, Then D Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then D, Then A Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then D, Then B Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment D, Then A, Then B Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment D, Then B, Then A Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then B, Then C Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then A, Then C Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then C, Then A Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then C, Then B Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment C, Then A, Then B Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment C, Then B, Then A Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.
Period-2 (8 Days) Withdrawal by Subject	0	0	1	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Intranasal SB-705498 in Allergic Rhinitis (AR) Patients

Baseline characteristics by cohort

Measure	Treatment A First, Then B, Then D n=7 Participants Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B First, Then A, Then D n=8 Participants Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then D, Then A n=8 Participants Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then D, Then B n=8 Participants Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment D, Then A, Then B n=8 Participants Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment D, Then B, Then A n=8 Participants Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then B, Then C n=4 Participants Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then A, Then C n=4 Participants Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment B, Then C, Then A n=4 Participants Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment A, Then C, Then B n=3 Participants Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment C, Then A, Then B n=4 Participants Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Treatment C, Then B, Then A n=4 Participants Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril \[each of 1.5mg\] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril \[each of 25μg\] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods.	Total n=70 Participants Total of all reporting groups
Age, Continuous	29.6 Years STANDARD_DEVIATION 5.65 • n=5 Participants	29.6 Years STANDARD_DEVIATION 9.24 • n=7 Participants	28.0 Years STANDARD_DEVIATION 5.07 • n=5 Participants	28.5 Years STANDARD_DEVIATION 9.20 • n=4 Participants	28.5 Years STANDARD_DEVIATION 6.46 • n=21 Participants	27.8 Years STANDARD_DEVIATION 6.34 • n=8 Participants	24.5 Years STANDARD_DEVIATION 3.11 • n=8 Participants	32.5 Years STANDARD_DEVIATION 10.54 • n=24 Participants	25.3 Years STANDARD_DEVIATION 1.50 • n=42 Participants	24.0 Years STANDARD_DEVIATION 1.00 • n=42 Participants	28.3 Years STANDARD_DEVIATION 6.29 • n=42 Participants	26.8 Years STANDARD_DEVIATION 11.03 • n=42 Participants	28.1 Years STANDARD_DEVIATION 6.86 • n=36 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	33 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	37 Participants n=36 Participants
Race/Ethnicity, Customized White(Wh)-Wh/Caucasian(Ca)/European(Eu)Heritage(H)	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	67 Participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native Wh-Wh/Ca/Eu H	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Wh - Arabic/North African H	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Asian - South East Asian H	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day 8 of each treatment period

Population: All subjects population. Only those participants available at the specified time points were analyzed.

Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Weighted mean (WM) of TNSS and its individual components (nasal congestion, rhinorrhoea, itching and sneezing) are presented on Day 8. Weighted mean was calculated over the time interval 0 to 4 hours after start of allergen chamber challenge by calculating the area under the curve of TNSS/component from time of the first observation to time of the last observation (AUC [tf-t1 hours]) using the trapezoidal rule, and then dividing by the actual relevant time interval (tf-t1) required by participant to complete the chamber challenge assessments. A Bayesian analysis was conducted to derive the posterior probability for TNSS.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 TNSS WM	6.53 Score on scale Standard Deviation 2.300	3.65 Score on scale Standard Deviation 2.360	6.57 Score on scale Standard Deviation 2.418	4.14 Score on scale Standard Deviation 2.243
Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 Nasal congestion scoreWM	1.80 Score on scale Standard Deviation 0.653	1.15 Score on scale Standard Deviation 0.792	1.82 Score on scale Standard Deviation 0.648	1.18 Score on scale Standard Deviation 0.715
Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 Rhinorrhoea score WM	1.67 Score on scale Standard Deviation 0.693	0.94 Score on scale Standard Deviation 0.726	1.75 Score on scale Standard Deviation 0.697	1.05 Score on scale Standard Deviation 0.687
Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 Nasal itching score WM	1.67 Score on scale Standard Deviation 0.760	0.94 Score on scale Standard Deviation 0.708	1.57 Score on scale Standard Deviation 0.886	1.17 Score on scale Standard Deviation 0.699
Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 Sneezing score WM	1.39 Score on scale Standard Deviation 0.763	0.62 Score on scale Standard Deviation 0.573	1.43 Score on scale Standard Deviation 0.785	0.74 Score on scale Standard Deviation 0.560

SECONDARY outcome

Timeframe: pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8 of each treatment period

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Mean of TNSS and its individual components is presented pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=47 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Mean TNSS and Its Individual Components From Day 4 to Day 8 TNSS,Day 4, pre-pm dose	3.6 Score on a scale Standard Deviation 2.47	2.4 Score on a scale Standard Deviation 2.20	3.3 Score on a scale Standard Deviation 2.65	2.6 Score on a scale Standard Deviation 1.94
Mean TNSS and Its Individual Components From Day 4 to Day 8 TNSS,Day 5, pre-pm dose	3.6 Score on a scale Standard Deviation 2.58	2.0 Score on a scale Standard Deviation 2.24	2.9 Score on a scale Standard Deviation 2.60	2.3 Score on a scale Standard Deviation 2.10
Mean TNSS and Its Individual Components From Day 4 to Day 8 TNSS,Day 6, pre-pm dose	3.3 Score on a scale Standard Deviation 2.45	1.8 Score on a scale Standard Deviation 2.03	2.8 Score on a scale Standard Deviation 2.74	2.0 Score on a scale Standard Deviation 2.03
Mean TNSS and Its Individual Components From Day 4 to Day 8 TNSS,Day 7, pre-pm dose	3.2 Score on a scale Standard Deviation 2.26	1.7 Score on a scale Standard Deviation 1.90	2.2 Score on a scale Standard Deviation 2.37	1.9 Score on a scale Standard Deviation 2.12
Mean TNSS and Its Individual Components From Day 4 to Day 8 TNSS,Day 8, pre-challenge (1hr)	2.0 Score on a scale Standard Deviation 1.88	1.3 Score on a scale Standard Deviation 1.60	1.9 Score on a scale Standard Deviation 1.52	1.1 Score on a scale Standard Deviation 1.45
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal congestion score code,Day 4, pre-pm dose	1.0 Score on a scale Standard Deviation 0.81	0.8 Score on a scale Standard Deviation 0.69	0.9 Score on a scale Standard Deviation 0.95	0.7 Score on a scale Standard Deviation 0.65
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal congestion score code,Day 5, pre-pm dose	0.9 Score on a scale Standard Deviation 0.82	0.7 Score on a scale Standard Deviation 0.70	0.7 Score on a scale Standard Deviation 0.88	0.6 Score on a scale Standard Deviation 0.64
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal congestion score code,Day 6, pre-pm dose	0.9 Score on a scale Standard Deviation 0.80	0.7 Score on a scale Standard Deviation 0.74	0.8 Score on a scale Standard Deviation 0.83	0.6 Score on a scale Standard Deviation 0.68
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal congestion score code,Day 7, pre-pm dose	0.8 Score on a scale Standard Deviation 0.69	0.6 Score on a scale Standard Deviation 0.62	0.7 Score on a scale Standard Deviation 0.82	0.6 Score on a scale Standard Deviation 0.65
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal congestion score code,Day 8, pre-challenge	0.7 Score on a scale Standard Deviation 0.67	0.6 Score on a scale Standard Deviation 0.67	0.6 Score on a scale Standard Deviation 0.59	0.4 Score on a scale Standard Deviation 0.58
Mean TNSS and Its Individual Components From Day 4 to Day 8 Rhinorrhoea score code,Day 4, pre-pm dose	0.9 Score on a scale Standard Deviation 0.71	0.6 Score on a scale Standard Deviation 0.76	0.9 Score on a scale Standard Deviation 0.87	0.5 Score on a scale Standard Deviation 0.65
Mean TNSS and Its Individual Components From Day 4 to Day 8 Rhinorrhoea score code,Day 5, pre-pm dose	0.9 Score on a scale Standard Deviation 0.75	0.5 Score on a scale Standard Deviation 0.78	0.9 Score on a scale Standard Deviation 0.90	0.5 Score on a scale Standard Deviation 0.66
Mean TNSS and Its Individual Components From Day 4 to Day 8 Rhinorrhoea score code,Day 6, pre-pm dose	0.8 Score on a scale Standard Deviation 0.73	0.4 Score on a scale Standard Deviation 0.65	0.8 Score on a scale Standard Deviation 0.90	0.6 Score on a scale Standard Deviation 0.62
Mean TNSS and Its Individual Components From Day 4 to Day 8 Rhinorrhoea score code,Day 7, pre-pm dose	0.8 Score on a scale Standard Deviation 0.65	0.4 Score on a scale Standard Deviation 0.62	0.6 Score on a scale Standard Deviation 0.78	0.4 Score on a scale Standard Deviation 0.69
Mean TNSS and Its Individual Components From Day 4 to Day 8 Rhinorrhoea score code,Day 8, pre-challenge (1hr)	0.6 Score on a scale Standard Deviation 0.69	0.3 Score on a scale Standard Deviation 0.59	0.6 Score on a scale Standard Deviation 0.66	0.3 Score on a scale Standard Deviation 0.50
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal itching score code,Day 4, pre-pm dose	0.9 Score on a scale Standard Deviation 0.85	0.5 Score on a scale Standard Deviation 0.66	0.7 Score on a scale Standard Deviation 0.71	0.7 Score on a scale Standard Deviation 0.71
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal itching score code,Day 5, pre-pm dose	0.8 Score on a scale Standard Deviation 0.81	0.4 Score on a scale Standard Deviation 0.63	0.4 Score on a scale Standard Deviation 0.66	0.7 Score on a scale Standard Deviation 0.75
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal itching score code,Day 6, pre-pm dose	0.8 Score on a scale Standard Deviation 0.84	0.3 Score on a scale Standard Deviation 0.58	0.5 Score on a scale Standard Deviation 0.73	0.5 Score on a scale Standard Deviation 0.72
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal itching score code,Day 7, pre-pm dose	0.8 Score on a scale Standard Deviation 0.80	0.4 Score on a scale Standard Deviation 0.62	0.3 Score on a scale Standard Deviation 0.65	0.5 Score on a scale Standard Deviation 0.72
Mean TNSS and Its Individual Components From Day 4 to Day 8 Nasal itching score code,Day 8, pre-challenge (1hr	0.5 Score on a scale Standard Deviation 0.65	0.3 Score on a scale Standard Deviation 0.60	0.3 Score on a scale Standard Deviation 0.49	0.3 Score on a scale Standard Deviation 0.55
Mean TNSS and Its Individual Components From Day 4 to Day 8 Sneezing score code,Day 4, pre-pm dose	0.9 Score on a scale Standard Deviation 0.78	0.5 Score on a scale Standard Deviation 0.68	0.9 Score on a scale Standard Deviation 0.87	0.6 Score on a scale Standard Deviation 0.68
Mean TNSS and Its Individual Components From Day 4 to Day 8 Sneezing score code,Day 5, pre-pm dose	0.9 Score on a scale Standard Deviation 0.85	0.4 Score on a scale Standard Deviation 0.67	0.8 Score on a scale Standard Deviation 0.83	0.4 Score on a scale Standard Deviation 0.65
Mean TNSS and Its Individual Components From Day 4 to Day 8 Sneezing score code,Day 6, pre-pm dose	0.8 Score on a scale Standard Deviation 0.82	0.4 Score on a scale Standard Deviation 0.57	0.7 Score on a scale Standard Deviation 0.92	0.4 Score on a scale Standard Deviation 0.68
Mean TNSS and Its Individual Components From Day 4 to Day 8 Sneezing score code,Day 7, pre-pm dose	0.8 Score on a scale Standard Deviation 0.75	0.3 Score on a scale Standard Deviation 0.55	0.5 Score on a scale Standard Deviation 0.73	0.4 Score on a scale Standard Deviation 0.61
Mean TNSS and Its Individual Components From Day 4 to Day 8 Sneezing score code,Day 8, pre-challenge (1hr)	0.3 Score on a scale Standard Deviation 0.51	0.1 Score on a scale Standard Deviation 0.26	0.4 Score on a scale Standard Deviation 0.58	0.1 Score on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: Day 8

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

Total Nasal Airflow is calculated as the sum of the left nostril and the right nostril airflow values. AAR is a very sensitive method of assessing clinical parameters of nasal obstruction (nasal flow, nasal resistance and nasal flow increase). A participant was instructed to breathe through one nostril while a sensor in the other nostril measured the difference in pre-nasal and choanal pressure. The system was connected to a computer. Nasal flow and nasal resistance were observed at pressure levels of 75, 150 and 300 Pascal. The defined measuring range for the flow was +-1000 milliliter per second (mL/s). Weighted means for total nasal airflow Resistance was calculated by dividing the area under the curve between 1 and 4 hours (via the linear trapezoidal method) by the total duration that the participant took to complete the chamber challenge assessments.

Outcome measures

Measure	Placebo n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=70 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Total Nasal Airflow on Day 8 Measured Using Active Anterior Rhinomanometry (AAR)	306.99 Milliliters per second (mL/s) Standard Error 17.255	388.34 Milliliters per second (mL/s) Standard Error 17.207	299.68 Milliliters per second (mL/s) Standard Error 22.806	379.40 Milliliters per second (mL/s) Standard Error 18.783

SECONDARY outcome

Timeframe: Day 8

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

The RQLQ composed of 28 items covering 7 domains of health. Each question is scored on a scale of 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). 7 domains were: Activities (3 items):1, 2, 3;Sleep (3 items): 4, 5, 6; Non-nose/eye symptoms (7 items): 7, 8, 9, 10, 11, 12, 13; Practical Problems (3 items): 14, 15, 16; Nasal Symptoms (4 items): 17, 18, 19, 20; Eye Symptoms (4 items): 21, 22, 23, 24; Emotional (4 items): 25, 26, 27, 28 consisted of total 28 items. Domain activity score = total post-baseline score for individualized activity items answered on both visits divided by total Baseline score for individualized activity items answered on both visits multiplied by the Baseline score for item(s) missing post-baseline. The global RQLQ score was calculated by averaging all 28 item scores, which ranges from 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). Higher scores indicate worsening of symptoms.

Outcome measures

Measure	Placebo n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=70 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 or or SB-705498 Matching Placebo	1.67 Score on a scale Standard Error 0.119	0.99 Score on a scale Standard Error 0.118	1.66 Score on a scale Standard Error 0.177	1.14 Score on a scale Standard Error 0.135

SECONDARY outcome

Timeframe: Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)

Population: The 'Pharmacokinetic Population' is defined as participants in the 'All Subjects' population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed.

Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV.

Outcome measures

Measure	Placebo n=23 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=46 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Area Under Concentration-time Curve (AUC) for SB-705498 on Day 8	588.26 nanograms*hour per mililiter (ng.h/mL) Geometric Coefficient of Variation 71.4	608.84 nanograms*hour per mililiter (ng.h/mL) Geometric Coefficient of Variation 74.2	—	—

SECONDARY outcome

Timeframe: Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)

Population: Pharmacokinetic Population. Only those participants available at the indicated time points were analyzed.

Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as least squares geometric means with respective geometric coefficient of variation (% CV).

Outcome measures

Measure	Placebo n=23 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=46 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Maximum Observed Concentration (Cmax) for SB-705498 on Day 8	145.958 nanograms per mililiter (ng/mL) Geometric Coefficient of Variation 68.8	154.231 nanograms per mililiter (ng/mL) Geometric Coefficient of Variation 71.0	—	—

SECONDARY outcome

Timeframe: Up to Week 16

Population: All Subjects population. Only those participants available at the indicated time points were analyzed.

Vital signs assessment included heart rate, blood pressure, and temperature. Criteria for vital sign values meeting potential clinical concern included: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mm Hg), diastolic blood pressure (DBP) < 45 and > 100 mm Hg, temperature <36 and >37.5 Degree Celsius and heart Rate <40 and >110 beats per minute. Only parameters with PCI values are reported.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Temperature,Low,Follow up	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) Temperature,Low,period 3	2 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Day 8 of each treatment period

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, and QTc intervals. Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Change From Baseline in ECG Values: Heart Rate	-0.2 beats per minute (bpm) Standard Deviation 11.32	-4.7 beats per minute (bpm) Standard Deviation 10.80	-4.8 beats per minute (bpm) Standard Deviation 8.09	-2.6 beats per minute (bpm) Standard Deviation 11.19

SECONDARY outcome

Timeframe: Baseline and Day 8 of each treatment period

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, QTc corrected by Bazett's formula (QTcB) and QTc corrected by Fridericia's formula (QTcF). Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcF	-2.9 Milliseconds (msec) Standard Deviation 13.16	-4.4 Milliseconds (msec) Standard Deviation 13.37	-9.0 Milliseconds (msec) Standard Deviation 16.53	-1.9 Milliseconds (msec) Standard Deviation 13.33
Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcB	-3.6 Milliseconds (msec) Standard Deviation 17.30	-9.3 Milliseconds (msec) Standard Deviation 18.44	-13.9 Milliseconds (msec) Standard Deviation 20.79	-4.1 Milliseconds (msec) Standard Deviation 21.10
Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF PR Interval	2.7 Milliseconds (msec) Standard Deviation 8.31	-1.2 Milliseconds (msec) Standard Deviation 9.38	4.5 Milliseconds (msec) Standard Deviation 9.29	0.4 Milliseconds (msec) Standard Deviation 9.73
Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QRS Duration	0.8 Milliseconds (msec) Standard Deviation 6.30	2.2 Milliseconds (msec) Standard Deviation 5.52	0.8 Milliseconds (msec) Standard Deviation 5.92	-0.2 Milliseconds (msec) Standard Deviation 5.05
Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QT Interval	-1.5 Milliseconds (msec) Standard Deviation 21.47	4.6 Milliseconds (msec) Standard Deviation 22.12	-0.3 Milliseconds (msec) Standard Deviation 17.50	2.5 Milliseconds (msec) Standard Deviation 17.93

SECONDARY outcome

Timeframe: Up to Week 16

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

The PCC range for hematology parameters included white blood cell count, low: 0.67, high 1.82, neutrophil count, low: 0.83, Hemoglobin, male- high 1.03, female- high 1.13, hematocrit, male- high 1.02, female- high 1.17, Platelet Count, low: 0.67, high: 1.57, lymphocytes, low 0.81. Only parameters with PCI values are reported.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Number of Participants With Hematology Parameters of PCI Hemoglobin,high	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Parameters of PCI Total Neutrophils,low	7 Participants	9 Participants	2 Participants	4 Participants
Number of Participants With Hematology Parameters of PCI Hematocrit,high	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: All subjects population. Only those participants available at the indicated time points were analyzed.

The PCC range for clinical chemistry parameters included albumin, low: 0.86, millimole per liter (mmol)/L, calcium, low: 0.91, high: 1.06, glucose. Low: 0.71, high: 1.41, Potassium, low: 0.86, high: 1.10, Sodium, low: 0.96, high: 1.03, Total CO2, Low: 0.86, high: 1.14, Creatinine, in male, Low: <75 micromole per liter (μmol/L), high: >110 μmol/L, female, Low: <65 μmol/L, high: >95, Blood Urea Nitrogen (BUN), high: >1.5xULN mmol/L, Uric Acid, in male, Low: < 180 μmol/L, high: > 480 μmol/L, female, Low: < 120 μmol/L, high: > 420. Only parameters with PCI values are reported.

Outcome measures

Measure	Placebo n=68 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 Participants Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 Participants Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=46 Participants Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Number of Participants With Clinical Biochemistry Parameters of PCI Creatinine,Low	19 Participants	25 Participants	6 Participants	14 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Creatinine,High	2 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Aspartate Amino Transferase,High	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Potassium,High	2 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Uric acid,High	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Gamma Glutamyl Transferase,High	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Total Bilirubin,High	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Clinical Biochemistry Parameters of PCI Alanine Amino Transferase,High	0 Participants	2 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

FP 200 μg

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

SB-705498 12 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

SB-705498 + FP 12 mg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=68 participants at risk Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	FP 200 μg n=69 participants at risk Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation.	SB-705498 12 mg n=23 participants at risk Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.	SB-705498 + FP 12 mg n=47 participants at risk Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B.
Immune system disorders Hypersensitivity	17.6% 12/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	15.9% 11/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	30.4% 7/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	21.3% 10/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Immune system disorders Food allergy	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Nervous system disorders Headache	13.2% 9/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	15.9% 11/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	21.7% 5/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	10.6% 5/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Nervous system disorders Migraine	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Nasal discomfort	4.4% 3/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.9% 2/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Cough	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.1% 1/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.1% 1/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Sneezing	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.1% 1/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Infections and infestations Nasopharyngitis	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	4.3% 1/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.1% 1/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Infections and infestations Influenza	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.9% 2/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.1% 1/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Infections and infestations Oral herpes	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Infections and infestations Urinary tract infection	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Gastrointestinal disorders Toothache	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Gastrointestinal disorders Diarrhoea	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	4.3% 1/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Gastrointestinal disorders Vomiting	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	4.3% 1/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Eye disorders Conjunctivitis	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	2.1% 1/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Eye disorders Eye irritation	1.5% 1/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
General disorders Pyrexia	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	4.3% 1/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events
Injury, poisoning and procedural complications Procedural pain	0.00% 0/68 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	1.4% 1/69 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/23 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events	0.00% 0/47 • Non-SAEs and SAEs were collected from start of the treatment up to Week 16. All subject population was used for collection of adverse events

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