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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00845195
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Olopatadine HCl Nasal Spray, 0.6%; Drug: Azelastine HCl Nasal Spray, 0.1%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olopatadine HCl Nasal Spray, 0.6%	Drug: Olopatadine HCl Nasal Spray, 0.6%; 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
Active Comparator: Azelastine HCl Nasal Spray, 0.1%	Drug: Azelastine HCl Nasal Spray, 0.1%; 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days

Outcome Measures

Primary Outcome Measures

1. Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline [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.

2. Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline [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.

3. Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline [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.

4. Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to provide consent/assent

• History of spring/summer allergic rhinitis

• Positive skin prick and/or intradermal test

• Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations

• Non-pregnant (where applicable)

• Able to complete daily diary

Exclusion Criteria:

• Smoker

• Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps

• History of current chronic sinusitis

• Asthma

• Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines

• History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses

• History or evidence of nasolacrimal drainage system malfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00845195
• Other Study ID Numbers: SMA-08-23
• First Posted: Feb 18, 2009
• Last Update Posted: Apr 27, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Rhinitis; Allergy; Nasal Spray; Antihistamine; Intranasal Corticosteroid
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Olopatadine Hydrochloride; Azelastine

Study Results

Participant Flow

Recruitment Details	March 8, 2009 - April 22, 2009

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%	Azelastine HCl Nasal Spray, 0.1%
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Period Title: Overall Study
STARTED	75	75
COMPLETED	75	75
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%	Azelastine HCl Nasal Spray, 0.1%	Total
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg	Total of all reporting groups
Overall Participants	75	75	150
Age (Count of Participants)
<=18 years	6 8%	5 6.7%	11 7.3%
Between 18 and 65 years	69 92%	70 93.3%	139 92.7%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	36 48%	45 60%	81 54%
Male	39 52%	30 40%	69 46%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
Description	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.
Time Frame	14 days minus baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%	Azelastine HCl Nasal Spray, 0.1%
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Measure Participants	67	68
Mean (Standard Deviation) [Units on a scale]	4.28 (2.63)	4.15 (2.63)

2. Primary Outcome

Title	Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
Description	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.
Time Frame	14 days minus baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%	Azelastine HCl Nasal Spray, 0.1%
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Measure Participants	67	68
Mean (Standard Deviation) [Units on a scale]	4.22 (2.69)	4.04 (2.45)

3. Primary Outcome

Title	Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline
Description	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.
Time Frame	14 days minus baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%	Azelastine HCl Nasal Spray, 0.1%
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Measure Participants	67	68
Mean (Standard Deviation) [Units on a scale]	2.64 (2.13)	2.49 (2.07)

4. Primary Outcome

Title	Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
Description	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.
Time Frame	14 days minus baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%	Azelastine HCl Nasal Spray, 0.1%
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg	Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
Measure Participants	67	68
Mean (Standard Deviation) [Units on a scale]	2.76 (2.21)	2.54 (2.08)

Adverse Events

Arm/Group Title	Olopatadine HCl Nasal Spray, 0.6%		Azelastine HCl Nasal Spray, 0.1%
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg		Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
All Cause Mortality
	Olopatadine HCl Nasal Spray, 0.6%		Azelastine HCl Nasal Spray, 0.1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Olopatadine HCl Nasal Spray, 0.6%		Azelastine HCl Nasal Spray, 0.1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Olopatadine HCl Nasal Spray, 0.6%		Azelastine HCl Nasal Spray, 0.1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.