Olopatadine Hydrochloride (Page 4 of 6)

14 CLINICAL STUDIES

Adult and Adolescent Patients 12 Years of Age and Older

The efficacy and safety of olopatadine hydrochloride nasal spray were evaluated in 3 randomized, double blind, parallel group, multicenter, placebo-controlled clinical trials (vehicle nasal spray) of 2 weeks duration in adult and adolescent patients, 12 years of age and older with symptoms of seasonal allergic rhinitis. The 3 clinical trials were conducted in the United States and included 1598 patients (556 males, and 1042 females) 12 years of age and older. In these 3 trials, 587 patients were treated with olopatadine hydrochloride nasal spray 0.6%, 418 patients were treated with olopatadine hydrochloride nasal spray 0.4%, and 593 patients were treated with vehicle nasal spray. Assessment of efficacy was based on patient recording of 4 individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective or instantaneous scores. Reflective scoring required patients to record symptom severity over the previous 12 hours; the instantaneous scoring required patients to record symptom severity at the time of recording. The primary efficacy endpoint was the difference from placebo in the percent change from baseline in the average of morning and evening reflective total nasal symptom score (rTNSS) averaged for the 2-week treatment period. In all 3 trials, patients treated with olopatadine hydrochloride nasal spray, two sprays per nostril, twice-daily, exhibited statistically significantly greater decreases in rTNSS compared to vehicle nasal spray. Results for the rTNSS from 2 representative trials are shown in Table 3.

Table 3: Mean Reflective Total Nasal Symptom Score (rTNSS) in Adult and Adolescent Patients With Seasonal Allergic Rhinitis

Study No.

Treatment

N

Baseline

Change from Baseline

Difference from Placebo

Estimate

95% CI

p-value

Study 1

Olopatadine Hydrochloride Nasal Spray

0.6%

183

8.71

-3.63

-0.96

(-1.42, -0.51)

<0.0001

Olopatadine Hydrochloride Nasal Spray

0.4%

188

8.90

-3.38

-0.71

(-1.17, -0.26)

0.0023

Vehicle Nasal Spray

191

8.75

-2.67

Study 2

Olopatadine Hydrochloride Nasal Spray

0.6%

220

9.17

-2.90

-0.98

(-1.37, -0.59)

<0.0001

Olopatadine Hydrochloride Nasal Spray

0.4%

228

9.26

-2.63

-0.72

(-1.11, -0.33)

0.0003

Vehicle Nasal Spray

223

9.07

-1.92

Abbreviation: CI, confidence interval.

Itchy eyes and watery eyes were evaluated as secondary endpoints but eye redness was not evaluated. In 2 of the studies, patients treated with olopatadine hydrochloride nasal spray had significantly greater decreases in reflective symptom scores for itchy eyes and watery eyes, compared to vehicle nasal spray.

In the 2-week seasonal allergy trials, onset of action was also evaluated by instantaneous TNSS assessments twice-daily after the first dose of study medication. In these trials, onset of action was seen after 1 day of dosing. Onset of action was evaluated in 3 environmental exposure unit studies with single doses of olopatadine hydrochloride nasal spray. In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen in the environmental exposure unit and then treated with either olopatadine hydrochloride nasal spray or vehicle nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly as instantaneous scores for the subsequent 12 hours. Olopatadine hydrochloride nasal spray 0.6% was found to have an onset of action of 30 minutes after dosing in the environmental exposure unit.

Pediatric Patients 6 to 11 Years of Age

There were 3 clinical trials of 2 weeks duration with olopatadine nasal spray in patients 6 to 11 years of age with seasonal allergic rhinitis. Efficacy of olopatadine hydrochloride nasal spray was evaluated in 2 of the 3 trials. One of the 2 trials that showed efficacy was a randomized, double blind, parallel group, multicenter, placebo (vehicle nasal spray)-controlled clinical trial of 2 weeks duration, including 1188 children ages 6 to < 12 years with seasonal allergic rhinitis. Assessment of efficacy was based on patient/caregiver recording of 4 individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective or instantaneous scores. Reflective scoring captured symptom severity over the previous 12 hours; the instantaneous scoring captured symptom severity at the time of recording. The primary efficacy endpoint was the difference from placebo in the percent change from baseline in the average of patient/caregiver-reported morning and evening reflective total nasal symptom score (rTNSS) averaged for the 2-week treatment period. Patients treated with olopatadine hydrochloride nasal spray, one or two sprays per nostril twice daily, had statistically significantly greater decreases in rTNSS compared to vehicle nasal spray. Results for rTNSS are shown in Table 4.

Table 4: Mean Reflective Total Nasal Symptom Score in Pediatric Patients 6 to 11 Years of Age With Seasonal Allergic Rhinitis

Treatment

N

Baseline

Change from Baseline

Difference from Placebo

Estimate

95% CI

p-value

Olopatadine Hydrochloride Nasal Spray

0.6%, one spray per nostril twice daily

294

8.99

-2.24

-0.55

(-0.90, -0.19)

0.0015

Vehicle Nasal Spray, one spray per nostril twice daily

294

9.09

-1.70

Abbreviation: CI, confidence interval.

Itchy eyes and watery eyes were evaluated as secondary endpoints in the same study but eye redness was not evaluated. Patients treated with olopatadine hydrochloride nasal spray had significantly greater decreases in reflective symptom scores for itchy eyes and watery eyes, compared to vehicle nasal spray.

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