Trial Outcomes & Findings for Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial (NCT NCT00691665)

Results Overview

Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

130 participants

Primary outcome timeframe

14 Days minus baseline

Results posted on

2010-03-30

Participant Flow

Study recruitment occurred from May 14, 2008 - July 31, 2008.

Participant milestones

Participant milestones
Measure	Olopatadine HCL Nasal Spray, 0.6% Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 Mcg Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Overall Study STARTED	65	65
Overall Study COMPLETED	65	65
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olopatadine HCL Nasal Spray, 0.6% n=65 Participants Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 Mcg n=65 Participants Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=93 Participants	2 Participants n=4 Participants	10 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=93 Participants	63 Participants n=4 Participants	118 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Gender Female	34 participants n=93 Participants	30 participants n=4 Participants	64 participants n=27 Participants
Gender Male	30 participants n=93 Participants	33 participants n=4 Participants	63 participants n=27 Participants

PRIMARY outcome

Timeframe: 14 Days minus baseline

Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.

Outcome measures

Outcome measures
Measure	Olopatadine HCL Nasal Spray, 0.6% n=65 Participants Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 Mcg n=65 Participants Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline	-45.37 Percent change Standard Deviation 31.77	-47.35 Percent change Standard Deviation 32.83

PRIMARY outcome

Timeframe: 14 days minus baseline

Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.

Outcome measures

Outcome measures
Measure	Olopatadine HCL Nasal Spray, 0.6% n=65 Participants Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 Mcg n=65 Participants Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline	-45.26 Percent change Standard Deviation 27.93	-48.8 Percent change Standard Deviation 30.10

PRIMARY outcome

Timeframe: 14 Days minus baseline

Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.

Outcome measures

Outcome measures
Measure	Olopatadine HCL Nasal Spray, 0.6% n=65 Participants Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 Mcg n=65 Participants Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline	-38.52 Percent change Standard Deviation 59.80	-40.59 Percent change Standard Deviation 55.66

PRIMARY outcome

Timeframe: 14 Days minus baseline

Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.

Outcome measures

Outcome measures
Measure	Olopatadine HCL Nasal Spray, 0.6% n=65 Participants Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 Mcg n=65 Participants Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline	-36.54 Percent change Standard Deviation 60.26	-41.63 Percent change Standard Deviation 50.46

Adverse Events

Olopatadine HCL Nasal Spray, 0.6%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluticasone Propionate Nasal Spray, 50 Mcg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place