Trial Outcomes & Findings for Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958 (NCT NCT02446613)

Last Updated: 2018-04-04

Results Overview

TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Day 1 (Baseline [pre-NAC] and post-NAC 15 min)

Results posted on

2018-04-04

Participant Flow

Participants (par) of All subjects population (ASP) from study TL7116958 who passed screening for study 204509 were used as safety population for this study. All outputs using information from study TL7116958 were analyzed using ASP and stand alone outputs for this study were analyzed using Safety population.

Participants with respiratory allergy/allergies, with or without asthma, who completed the parent study TL7116958 in 2014 were enrolled to investigate the long term effect of previous treatment with GSK2245035 compared to placebo on total nasal symptoms (sym.) elicited by allergen challenge.

Participant milestones

Participant milestones
Measure	Placebo Once Weekly Participants were not administered with placebo during the current study (204509). Participants were subjected to nasal allergen challenge (NAC) at Visit 2 to investigate the long term effect of matching placebo, intranasal (i.n.), administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 hours (h) post NAC.	GSK2245035 20 ng, i.n., Once Weekly Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 nanograms (ng), i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post NAC.
Overall Study STARTED	6	10
Overall Study COMPLETED	6	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	Total n=16 Participants Total of all reporting groups
Age, Continuous	41.3 Years STANDARD_DEVIATION 12.82 • n=5 Participants	40.4 Years STANDARD_DEVIATION 12.02 • n=7 Participants	40.8 Years STANDARD_DEVIATION 11.90 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)

Population: The Safety population consisted of members of the ASP of parent study TL7116958 who had passed screening for study 204509.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)	3.8 Score on a scale Interval 1.22 to 6.53	5.9 Score on a scale Interval 3.91 to 7.81

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)

Population: Safety population

TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Mean Change From Baseline in the TNSS Over Post-NAC 1 h	2.4 Score on a scale Interval 0.24 to 4.63	3.4 Score on a scale Interval 1.7 to 4.96

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Population: Safety population

TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Mean Change From Baseline in the TNSS Over Post-NAC 6 h	1.2 Score on a scale Interval 0.04 to 2.33	1.6 Score on a scale Interval 0.73 to 2.44

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Population: Safety population

TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h	4.1 Score on a scale Interval 1.41 to 6.8	5.9 Score on a scale Interval 3.83 to 7.87

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] and post-NAC 15 min)

Population: Safety population

PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min	27.6 Percent change Interval 15.87 to 39.63	32.2 Percent change Interval 23.71 to 40.72

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] to post-NAC 1 h)

Population: Safety population

PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Percent Change From Baseline in the PNIF Over Post-NAC 1 h	20.8 Percent change Interval 5.45 to 35.84	25.0 Percent change Interval 14.69 to 36.05

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Population: Safety populaton

PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Percent Change From Baseline in the PNIF up to Post-NAC 6 h	6.3 Percent change Interval -7.56 to 20.47	7.3 Percent change Interval -2.98 to 17.68

PRIMARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Population: Safety population

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h	33.3 Percent change Interval 16.89 to 49.33	39.9 Percent change Interval 29.18 to 51.53

SECONDARY outcome

Timeframe: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

Population: Safety population

Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Placebo Once Weekly n=6 Participants Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 Participants Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Sneezing, 15 min	1.33 Score on a scale Standard Deviation 1.366	1.50 Score on a scale Standard Deviation 1.080
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Sneezing, WM 0-1 h	0.56 Score on a scale Standard Deviation 0.706	0.56 Score on a scale Standard Deviation 0.641
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Sneezing, WM 0-6 h	0.40 Score on a scale Standard Deviation 0.496	0.19 Score on a scale Standard Deviation 0.463
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Sneezing, Max 0-6 h	1.33 Score on a scale Standard Deviation 1.366	1.60 Score on a scale Standard Deviation 1.075
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Rhinorrhoea, 15 min	0.50 Score on a scale Standard Deviation 0.548	1.60 Score on a scale Standard Deviation 1.075
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Rhinorrhoea, WM 0-1 h	0.15 Score on a scale Standard Deviation 0.300	1.16 Score on a scale Standard Deviation 0.924
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Rhinorrhoea, WM 0-6 h	-0.06 Score on a scale Standard Deviation 0.383	0.60 Score on a scale Standard Deviation 0.791
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Rhinorrhoea, Max 0-6 h	0.50 Score on a scale Standard Deviation 0.548	1.60 Score on a scale Standard Deviation 1.075
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal itching , 15 min	0.67 Score on a scale Standard Deviation 1.033	1.50 Score on a scale Standard Deviation 0.850
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal itching , WM 0-1 h	0.44 Score on a scale Standard Deviation 0.832	1.15 Score on a scale Standard Deviation 0.733
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal itching , WM 0-6 h	0.05 Score on a scale Standard Deviation 0.684	0.60 Score on a scale Standard Deviation 0.556
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal itching , Max 0-6 h	0.83 Score on a scale Standard Deviation 0.753	1.60 Score on a scale Standard Deviation 0.843
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal blockage , 15 min	1.17 Score on a scale Standard Deviation 0.753	1.70 Score on a scale Standard Deviation 0.675
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal blockage , WM 0-1 h	0.73 Score on a scale Standard Deviation 0.533	1.26 Score on a scale Standard Deviation 0.641
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal blockage , WM 0-6 h	0.43 Score on a scale Standard Deviation 0.485	0.64 Score on a scale Standard Deviation 0.500
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. Nasal blockage , Max 0-6 h	1.33 Score on a scale Standard Deviation 0.816	1.80 Score on a scale Standard Deviation 0.632

Adverse Events

Placebo Once Weekly

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GSK2245035 20 ng, i.n., Once Weekly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Once Weekly n=6 participants at risk Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.	GSK2245035 20 ng, i.n., Once Weekly n=10 participants at risk Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
Infections and infestations Urinary tract infection	16.7% 1/6 • Serious adverse events (SAEs) were collected from participant's consent for participation in the study till follow-up contact (4 to 7 day post Visit 2). Adverse events (AEs) were collected from the start of Study Visit 2 NAC until the follow-up contact. Safety population was used to record AEs and SAEs. No SAEs were reported in the study.	0.00% 0/10 • Serious adverse events (SAEs) were collected from participant's consent for participation in the study till follow-up contact (4 to 7 day post Visit 2). Adverse events (AEs) were collected from the start of Study Visit 2 NAC until the follow-up contact. Safety population was used to record AEs and SAEs. No SAEs were reported in the study.
Metabolism and nutrition disorders Diabetes mellitus	16.7% 1/6 • Serious adverse events (SAEs) were collected from participant's consent for participation in the study till follow-up contact (4 to 7 day post Visit 2). Adverse events (AEs) were collected from the start of Study Visit 2 NAC until the follow-up contact. Safety population was used to record AEs and SAEs. No SAEs were reported in the study.	0.00% 0/10 • Serious adverse events (SAEs) were collected from participant's consent for participation in the study till follow-up contact (4 to 7 day post Visit 2). Adverse events (AEs) were collected from the start of Study Visit 2 NAC until the follow-up contact. Safety population was used to record AEs and SAEs. No SAEs were reported in the study.

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.
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