Trial Outcomes & Findings for Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis (NCT NCT00979615)

Results Overview

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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

129 participants

Primary outcome timeframe

2 week

Results posted on

2011-05-10

Participant Flow

September 9, 2009 - November 13, 2009

Participant milestones

Participant milestones
Measure	Olopatadine HCL Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl Azelastine HCl Nasal Spray, 137 mcg
Overall Study STARTED	63	66
Overall Study COMPLETED	57	58
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olopatadine HCL n=57 Participants Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=58 Participants Azelastine HCl Nasal Spray, 137 mcg	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	46 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 week

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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 n=57 Participants Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=58 Participants Azelastine HCl Nasal Spray, 137 mcg
Mean Change in 2-week rTNSS From Baseline	5.9 Units on a scale Standard Deviation 3.0	6.5 Units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 2 week

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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 n=44 Participants Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=43 Participants Azelastine HCl Nasal Spray, 137 mcg
Mean Change in Rhinorrhea Reflective Score	1.5 Units on a scale Standard Deviation 1.1	1.3 Units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 2 Weeks

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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 n=44 Participants Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=43 Participants Azelastine HCl Nasal Spray, 137 mcg
Mean Change Postnasal Drip Reflective Score	1.5 Units on a scale Standard Deviation 1.2	1.8 Units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 2 Weeks

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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 n=44 Participants Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=43 Participants Azelastine HCl Nasal Spray, 137 mcg
Mean Change Nasal Congestion Reflective Score	1.4 Units on a scale Standard Deviation 1.1	1.7 Units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 2 Weeks

Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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 n=44 Participants Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=43 Participants Azelastine HCl Nasal Spray, 137 mcg
Mean Change in Sneezing Reflective Score	1.4 Units on a scale Standard Deviation 0.9	1.7 Units on a scale Standard Deviation 0.8

Adverse Events

Olopatadine HCL

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Azelastine HCl

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olopatadine HCL n=63 participants at risk Olopatadine HCL Nasal Spray, 0.6%	Azelastine HCl n=66 participants at risk Azelastine HCl Nasal Spray, 137 mcg
Gastrointestinal disorders Taste Disturbance	4.8% 3/63 • Number of events 3 • Two weeks	9.1% 6/66 • Number of events 6 • Two weeks
Respiratory, thoracic and mediastinal disorders Nose Bleeds	3.2% 2/63 • Number of events 3 • Two weeks	4.5% 3/66 • Number of events 3 • Two weeks

Additional Information

Maria J. Tort, PhD

Alcon Research, Ltd.

Phone: (817) 302-5968

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place