Seasonal Allergic Rhinitis
Conditions
Keywords
allergic rhinitis, allergies, seasonal allergies
Brief summary
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.
Interventions
Olopatadine HCl 1 or 2 sprays per nostril twice daily
DRUGVehicle
Vehicle 1 or 2 sprays per nostril twice daily
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Male or female; minimum of 6 years of age and less than 12 years * 2 year history of seasonal allergic rhinitis
Exclusion criteria
* Concurrent disease that might interfere with the investigation or evaluation of te study medication * Confirmed diagnosis of chronic rhinosinusitis within the last year * Asthma, with the exception of mild intermittent asthma * Anatomical nasal deformity * Nasal obstruction * Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR) * Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids * Ocular disorder other that allergic conjunctivitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | Baseline through 2 weeks after randomization | Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | Baseline through 2 weeks after randomization | Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days. |
Countries
United States
Participant flow
Recruitment details
The first subject was enrolled in the study on September 8, 2007 and the last subject exited the study on November 24, 2008. The study was conducted at medical clinics throughout the USA.
Pre-assignment details
Subjects completed a 4-16 day run-in period on vehicle prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Olopatadine 0.6% 1 Spray Olopatadine HCl 0.6% 1 spray per nostril twice daily | 298 |
| Vehicle 1 Spray Vehicle 1 spray per nostril twice daily | 297 |
| Olopatadine 0.6% 2 Sprays Olopatadine HCl 0.6% 2 Sprays per nostril twice daily | 296 |
| Vehicle 2 Sprays Vehicle 2 sprays per nostril twice daily | 297 |
| Total | 1,188 |
Baseline characteristics
| Characteristic | Olopatadine 0.6% 1 Spray | Vehicle 1 Spray | Olopatadine 0.6% 2 Sprays | Vehicle 2 Sprays | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 298 Participants | 297 Participants | 296 Participants | 297 Participants | 1188 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 130 Participants | 125 Participants | 122 Participants | 124 Participants | 501 Participants |
| Sex: Female, Male Male | 168 Participants | 172 Participants | 174 Participants | 173 Participants | 687 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 298 | 21 / 297 | 26 / 296 | 30 / 297 | 107 / 2,388 |
| serious Total, serious adverse events | 0 / 298 | 0 / 297 | 0 / 296 | 0 / 297 | 1 / 2,388 |
Outcome results
Primary
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Time frame: Baseline through 2 weeks after randomization
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine 0.6% 1 Spray | Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | -25.10 Percent change of TNSS from baseline | Standard Error 1.45 |
| Vehicle 1 Spray | Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | -18.17 Percent change of TNSS from baseline | Standard Error 1.45 |
| Olopatadine 0.6% 2 Sprays | Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | -26.35 Percent change of TNSS from baseline | Standard Error 1.45 |
| Vehicle 2 Sprays | Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | -21.21 Percent change of TNSS from baseline | Standard Error 1.45 |
Secondary
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.
Time frame: Baseline through 2 weeks after randomization
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine 0.6% 1 Spray | Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | -25.02 Percent change of TOSS from baseline | Standard Error 5.11 |
| Vehicle 1 Spray | Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | -6.09 Percent change of TOSS from baseline | Standard Error 5.1 |
| Olopatadine 0.6% 2 Sprays | Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | -25.03 Percent change of TOSS from baseline | Standard Error 3.33 |
| Vehicle 2 Sprays | Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | -9.46 Percent change of TOSS from baseline | Standard Error 3.37 |