Trial Outcomes & Findings for Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid (NCT NCT00845195)

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

150 participants

Primary outcome timeframe

14 days minus baseline

Results posted on

2010-04-27

Participant Flow

March 8, 2009 - April 22, 2009

Participant milestones

Participant milestones
Measure	Olopatadine HCl Nasal Spray, 0.6% Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCl Nasal Spray, 0.1% Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Overall Study STARTED	75	75
Overall Study COMPLETED	75	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olopatadine HCl Nasal Spray, 0.6% n=75 Participants Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCl Nasal Spray, 0.1% n=75 Participants Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=93 Participants	70 Participants n=4 Participants	139 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	45 Participants n=4 Participants	81 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	30 Participants n=4 Participants	69 Participants n=27 Participants

PRIMARY outcome

Timeframe: 14 days minus baseline

Population: The analysis was per protocol. 15 patients were not included in the analysis.

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=67 Participants Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCl Nasal Spray, 0.1% n=68 Participants Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline	4.28 Units on a scale Standard Deviation 2.63	4.15 Units on a scale Standard Deviation 2.63

PRIMARY outcome

Timeframe: 14 days minus baseline

Population: The analysis was per protocol. 15 patients were not included in the analysis.

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=67 Participants Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCl Nasal Spray, 0.1% n=68 Participants Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline	4.22 Units on a scale Standard Deviation 2.69	4.04 Units on a scale Standard Deviation 2.45

PRIMARY outcome

Timeframe: 14 days minus baseline

Population: The analysis was per protocol. 15 patients were not included in the analysis.

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=67 Participants Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCl Nasal Spray, 0.1% n=68 Participants Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline	2.64 Units on a scale Standard Deviation 2.13	2.49 Units on a scale Standard Deviation 2.07

PRIMARY outcome

Timeframe: 14 days minus baseline

Population: The analysis was per protocol. 15 patients were not included in the analysis.

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=67 Participants Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCl Nasal Spray, 0.1% n=68 Participants Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline	2.76 Units on a scale Standard Deviation 2.21	2.54 Units on a scale Standard Deviation 2.08

Adverse Events

Olopatadine HCl Nasal Spray, 0.6%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Azelastine HCl Nasal Spray, 0.1%

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