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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00691665
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Olopatadine HCL Nasal Spray, 0.6%; Drug: Fluticasone Propionate Nasal Spray, 50 mcg	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olopatadine HCL Nasal Spray, 0.6% Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Drug: Olopatadine HCL Nasal Spray, 0.6%; Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Active Comparator: Fluticasone Propionate Nasal Spray, 50 mcg Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily	Drug: Fluticasone Propionate Nasal Spray, 50 mcg; Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Outcome Measures

Primary Outcome Measures

1. Mean Percent 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 Percent Change in Instantaneous Total Nasal Symptom Score (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.

3. Mean Percent 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.

4. Mean Percent 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: Yes

Inclusion:

• A history of spring/summer seasonal allergies.

• Positive skin prick test for the currently prevalent allergen of the area.

• Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.

• For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.

Exclusion:

• History of chronic sinusitis.

• Asthma, with the exception of intermittent asthma.

• Smokers.

• Known non-responders to antihistamines.

• Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.

• Chronic use of long acting antihistamines.

• Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.

• Relatives of study site staff or other individuals who had access to the clinical study protocol.

• Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sacramento, CA	Sacramento	California	United States	95819

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00691665
• Other Study ID Numbers: SMA-08-06
• First Posted: Jun 5, 2008
• Last Update Posted: Mar 30, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Rhinitis; Seasonal Allergic Rhinitis; allergies
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Fluticasone; Xhance; Olopatadine Hydrochloride

Study Results

Participant Flow

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

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%	Fluticasone Propionate Nasal Spray, 50 Mcg
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Period Title: Overall Study
STARTED	65	65
COMPLETED	65	65
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%	Fluticasone Propionate Nasal Spray, 50 Mcg	Total
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily	Total of all reporting groups
Overall Participants	65	65	130
Age (Count of Participants)
<=18 years	8 12.3%	2 3.1%	10 7.7%
Between 18 and 65 years	55 84.6%	63 96.9%	118 90.8%
>=65 years	2 3.1%	0 0%	2 1.5%
Gender (participants) [Number]
Female	34 52.3%	30 46.2%	64 49.2%
Male	30 46.2%	33 50.8%	63 48.5%

Outcome Measures

1. Primary Outcome

Title	Mean Percent 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

[Not Specified]

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%	Fluticasone Propionate Nasal Spray, 50 Mcg
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Measure Participants	65	65
Mean (Standard Deviation) [Percent change]	-45.37 (31.77)	-47.35 (32.83)

2. Primary Outcome

Title	Mean Percent Change in Instantaneous Total Nasal Symptom Score (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

[Not Specified]

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%	Fluticasone Propionate Nasal Spray, 50 Mcg
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Measure Participants	65	65
Mean (Standard Deviation) [Percent change]	-45.26 (27.93)	-48.8 (30.10)

3. Primary Outcome

Title	Mean Percent 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

[Not Specified]

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%	Fluticasone Propionate Nasal Spray, 50 Mcg
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Measure Participants	65	65
Mean (Standard Deviation) [Percent change]	-38.52 (59.80)	-40.59 (55.66)

4. Primary Outcome

Title	Mean Percent 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

[Not Specified]

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%	Fluticasone Propionate Nasal Spray, 50 Mcg
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Measure Participants	65	65
Mean (Standard Deviation) [Percent change]	-36.54 (60.26)	-41.63 (50.46)

Adverse Events

Arm/Group Title	Olopatadine HCL Nasal Spray, 0.6%		Fluticasone Propionate Nasal Spray, 50 Mcg
Arm/Group Description	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily		Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
All Cause Mortality
	Olopatadine HCL Nasal Spray, 0.6%		Fluticasone Propionate Nasal Spray, 50 Mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Olopatadine HCL Nasal Spray, 0.6%		Fluticasone Propionate Nasal Spray, 50 Mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	Olopatadine HCL Nasal Spray, 0.6%		Fluticasone Propionate Nasal Spray, 50 Mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/65 (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.