The purpose of this pilot study is to compare the effects (effectiveness and safety)of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]) with a placebo nasal spray for the treatment of irritant (non-allergic) rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
Fluticasone furoate nasal spray 110mcg intranasally once daily for 4 weeks
Matching placebo nasal spray intranasally once daily for 4 weeks
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Chiang Mai, Thailand
GSK Investigational Site
Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
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Khon Kaen, Thailand
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)
Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)
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.
Time frame: Baseline through Week 4 (28 days)