Trial Outcomes & Findings for A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis (NCT NCT00730756)

NCT ID: NCT00730756

Last Updated: 2017-04-06

Results Overview

The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 102 participants
• Primary outcome timeframe: Baseline through Week 4 (28 days)
• Results posted on: 2017-04-06

Participant Flow

Participant milestones

Measure	Placebo Vehicle placebo nasal spray once daily	FFNS 110 mcg Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Overall Study STARTED	49	53
Overall Study COMPLETED	45	48
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	Placebo Vehicle placebo nasal spray once daily	FFNS 110 mcg Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Overall Study Adverse Event	2	0
Overall Study Lack of Efficacy	1	1
Overall Study Protocol Deviation	1	2
Overall Study Lost to Follow-up	0	1
Overall Study Withdrew Consent	0	1

Baseline Characteristics

A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis

Baseline characteristics by cohort

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily	Total n=102 Participants Total of all reporting groups
Age, Continuous	35.9 years STANDARD_DEVIATION 10.89 • n=5 Participants	37.1 years STANDARD_DEVIATION 12.78 • n=7 Participants	36.6 years STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Asian	49 participants n=5 Participants	53 participants n=7 Participants	102 participants n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores Daily Reflective TNSS	6.4 points on a scale STANDARD_DEVIATION 1.16 • n=5 Participants	6.7 points on a scale STANDARD_DEVIATION 1.25 • n=7 Participants	6.5 points on a scale STANDARD_DEVIATION 1.22 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores Morning (AM) pre-dose instantaneous (i) TNSS	6.3 points on a scale STANDARD_DEVIATION 1.50 • n=5 Participants	6.5 points on a scale STANDARD_DEVIATION 1.57 • n=7 Participants	6.4 points on a scale STANDARD_DEVIATION 1.53 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores AM Reflective TNSS	6.4 points on a scale STANDARD_DEVIATION 1.24 • n=5 Participants	6.7 points on a scale STANDARD_DEVIATION 1.36 • n=7 Participants	6.5 points on a scale STANDARD_DEVIATION 1.30 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores Evening (PM) Reflective TNSS	6.3 points on a scale STANDARD_DEVIATION 1.31 • n=5 Participants	6.7 points on a scale STANDARD_DEVIATION 1.32 • n=7 Participants	6.5 points on a scale STANDARD_DEVIATION 1.32 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores Daily Reflective TOSS	2.4 points on a scale STANDARD_DEVIATION 2.17 • n=5 Participants	3.1 points on a scale STANDARD_DEVIATION 2.27 • n=7 Participants	2.8 points on a scale STANDARD_DEVIATION 2.24 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores AM pre-dose iTOSS	2.4 points on a scale STANDARD_DEVIATION 2.24 • n=5 Participants	3.1 points on a scale STANDARD_DEVIATION 2.17 • n=7 Participants	2.8 points on a scale STANDARD_DEVIATION 2.22 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores AM Reflective TOSS	2.4 points on a scale STANDARD_DEVIATION 2.20 • n=5 Participants	3.0 points on a scale STANDARD_DEVIATION 2.16 • n=7 Participants	2.7 points on a scale STANDARD_DEVIATION 2.19 • n=5 Participants
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores PM Reflective TOSS	2.4 points on a scale STANDARD_DEVIATION 2.19 • n=5 Participants	3.2 points on a scale STANDARD_DEVIATION 2.42 • n=7 Participants	2.8 points on a scale STANDARD_DEVIATION 2.34 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication

The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)	-2.10 points on a scale Standard Error 0.25	-2.17 points on a scale Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) AM pre-dose iTNSS	-1.82 points on a scale Standard Error 0.26	-1.90 points on a scale Standard Error 0.24
Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) AM rTNSS	-2.13 points on a scale Standard Error 0.27	-2.15 points on a scale Standard Error 0.24
Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) PM rTNSS	-2.09 points on a scale Standard Error 0.25	-2.19 points on a scale Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) Rhinorrhea	-0.64 points on a scale Standard Error 0.09	-0.72 points on a scale Standard Error 0.08
Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) Nasal congestion	-0.75 points on a scale Standard Error 0.09	-0.79 points on a scale Standard Error 0.08
Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) Post-nasal drip	-0.70 points on a scale Standard Error 0.10	-0.67 points on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) Rhinorrhea	-0.52 points on a scale Standard Error 0.09	-0.61 points on a scale Standard Error 0.09
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) Nasal congestion	-0.64 points on a scale Standard Error 0.09	-0.71 points on a scale Standard Error 0.08
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) Post-nasal drip	-0.66 points on a scale Standard Error 0.10	-0.58 points on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) AM, rhinorrhea	-0.65 points on a scale Standard Error 0.09	-0.72 points on a scale Standard Error 0.08
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) PM, rhinorrhea	-0.63 points on a scale Standard Error 0.09	-0.72 points on a scale Standard Error 0.09
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) AM, nasal congestion	-0.75 points on a scale Standard Error 0.09	-0.78 points on a scale Standard Error 0.08
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) PM, nasal congestion	-0.76 points on a scale Standard Error 0.09	-0.79 points on a scale Standard Error 0.09
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) AM, post-nasal drip	-0.73 points on a scale Standard Error 0.10	-0.65 points on a scale Standard Error 0.09
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) PM, post-nasal drip	-0.69 points on a scale Standard Error 0.10	-0.68 points on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) Daily rTOSS	-0.77 points on a scale Standard Error 0.16	-1.04 points on a scale Standard Error 0.14
Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) AM pre-dose iTOSS	-0.85 points on a scale Standard Error 0.17	-0.98 points on a scale Standard Error 0.15
Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) PM rTOSS	-0.74 points on a scale Standard Error 0.16	-1.13 points on a scale Standard Error 0.15
Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) AM rTOSS	-0.81 points on a scale Standard Error 0.17	-0.96 points on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) Eye itching/burning	-0.32 points on a scale Standard Error 0.07	-0.45 points on a scale Standard Error 0.06
Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) Eye tearing/watering	-0.29 points on a scale Standard Error 0.06	-0.31 points on a scale Standard Error 0.06
Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) Eye redness	-0.17 points on a scale Standard Error 0.06	-0.28 points on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) Eye itching/burning	-0.35 points on a scale Standard Error 0.08	-0.37 points on a scale Standard Error 0.07
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) Eye tearing/watering	-0.30 points on a scale Standard Error 0.06	-0.33 points on a scale Standard Error 0.06
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) Eye redness	-0.21 points on a scale Standard Error 0.05	-0.27 points on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline through Week 4 (28 days)

Population: ITT Population

Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.

Outcome measures

Measure	Placebo n=49 Participants Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) AM, eye itching/burning	-0.34 points on a scale Standard Error 0.07	-0.42 points on a scale Standard Error 0.06
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) PM, eye itching/burning	-0.30 points on a scale Standard Error 0.07	-0.48 points on a scale Standard Error 0.06
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) AM, eye tearing/watering	-0.32 points on a scale Standard Error 0.07	-0.29 points on a scale Standard Error 0.06
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) PM, eye tearing/watering	-0.27 points on a scale Standard Error 0.06	-0.33 points on a scale Standard Error 0.05
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) AM, eye redness	-0.16 points on a scale Standard Error 0.06	-0.23 points on a scale Standard Error 0.05
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) PM, eye redness	-0.19 points on a scale Standard Error 0.06	-0.31 points on a scale Standard Error 0.05

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

FFNS 110 mcg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=49 participants at risk Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 participants at risk Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.00% 0/49	1.9% 1/53

Other adverse events

Measure	Placebo n=49 participants at risk Vehicle placebo nasal spray once daily	FFNS 110 mcg n=53 participants at risk Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49	5.7% 3/53
Nervous system disorders Migraine	2.0% 1/49	3.8% 2/53
Respiratory, thoracic and mediastinal disorders Nasal ulcer	2.0% 1/49	3.8% 2/53
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/49	3.8% 2/53

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