Seasonal Allergic Rhinitis
Conditions
Keywords
Rhinitis, Allergy, Nasal Spray, Antihistamine, Intranasal Corticosteroid
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.
Interventions
2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
DRUGAzelastine 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
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
March 8, 2009 - April 22, 2009
Participants by arm
| Arm | Count |
|---|---|
| Olopatadine HCl Nasal Spray, 0.6% Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg | 75 |
| Azelastine HCl Nasal Spray, 0.1% Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Olopatadine HCl Nasal Spray, 0.6% | Azelastine HCl Nasal Spray, 0.1% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 70 Participants | 139 Participants |
| Sex: Female, Male Female | 36 Participants | 45 Participants | 81 Participants |
| Sex: Female, Male Male | 39 Participants | 30 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From 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.
Time frame: 14 days minus baseline
Population: The analysis was per protocol. 15 patients were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCl Nasal Spray, 0.6% | Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline | 2.64 Units on a scale | Standard Deviation 2.13 |
| Azelastine HCl Nasal Spray, 0.1% | Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline | 2.49 Units on a scale | Standard Deviation 2.07 |
Primary
Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From 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.
Time frame: 14 days minus baseline
Population: The analysis was per protocol. 15 patients were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCl Nasal Spray, 0.6% | Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline | 2.76 Units on a scale | Standard Deviation 2.21 |
| Azelastine HCl Nasal Spray, 0.1% | Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline | 2.54 Units on a scale | Standard Deviation 2.08 |
Primary
Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From 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.
Time frame: 14 days minus baseline
Population: The analysis was per protocol. 15 patients were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCl Nasal Spray, 0.6% | Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline | 4.28 Units on a scale | Standard Deviation 2.63 |
| Azelastine HCl Nasal Spray, 0.1% | Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline | 4.15 Units on a scale | Standard Deviation 2.63 |
Primary
Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From 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.
Time frame: 14 days minus baseline
Population: The analysis was per protocol. 15 patients were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCl Nasal Spray, 0.6% | Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline | 4.22 Units on a scale | Standard Deviation 2.69 |
| Azelastine HCl Nasal Spray, 0.1% | Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline | 4.04 Units on a scale | Standard Deviation 2.45 |