Perennial Allergic Rhinitis
Conditions
Keywords
rhinitis, perennial allergic rhinitis, allergic rhinitis
Brief summary
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
Interventions
DRUGOlopatadine 0.6% nasal spray
2 sprays each nostril twice daily
DRUGPlacebo Nasal Spray
2 sprays each 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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Exclusion criteria
* Age 11 years and younger
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire | day 30 | Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief. |
Secondary
| Measure | Time frame |
|---|---|
| Average Number of Days of Rescue Medication Taken | Month 1 through Month 12 |
Countries
United States
Participant flow
Recruitment details
Patients were recruited between December 2006 and January 2007 at medical offices in the United States.
Pre-assignment details
Patients were randomized at Visit 1 upon meeting inclusion/exclusion.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Nasal Spray | 445 |
| Olopatadine 0.6% Nasal Spray | 445 |
| Total | 890 |
Baseline characteristics
| Characteristic | Placebo Nasal Spray | Olopatadine 0.6% Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 53 Participants | 46 Participants | 99 Participants |
| Age, Categorical >=65 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 383 Participants | 388 Participants | 771 Participants |
| Sex: Female, Male Female | 296 Participants | 282 Participants | 578 Participants |
| Sex: Female, Male Male | 149 Participants | 163 Participants | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 319 / 445 | 309 / 445 |
| serious Total, serious adverse events | 15 / 445 | 15 / 445 |
Outcome results
Primary
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Time frame: day 30
Population: 29 patients had missing mean patient-rated relief assessment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Nasal Spray | Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire | 2.7 Unit on PRRA scale | Standard Deviation 0.9 |
| Olopatadine 0.6% Nasal Spray | Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire | 2.5 Unit on PRRA scale | Standard Deviation 0.9 |
Secondary
Average Number of Days of Rescue Medication Taken
Time frame: Month 1 through Month 12
Population: 12 patients had missing average use of rescue medication data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Nasal Spray | Average Number of Days of Rescue Medication Taken | 10.2 Days | Standard Deviation 22.4 |
| Olopatadine 0.6% Nasal Spray | Average Number of Days of Rescue Medication Taken | 11.8 Days | Standard Deviation 26.6 |