QNASL (Page 5 of 8)

14 CLINICAL STUDIES

14.1 Seasonal and Perennial Allergic Rhinitis

Adult and Adolescent Patients Aged 12 Years and Older: The efficacy and safety of QNASL Nasal Aerosol have been evaluated in 3 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 6 weeks duration in adult and adolescent patients 12 years and older with symptoms of seasonal or perennial allergic rhinitis. The 3 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis, one 2-week efficacy trial in patients with seasonal allergic rhinitis, and one 6-week efficacy trial in patients with perennial allergic rhinitis. The trials included a total of 1049 patients (366 males and 683 females). About 81% of patients were Caucasian and 17% African American, the mean age was approximately 38 years. Of these patients 521 received QNASL Nasal Aerosol 320 mcg once daily administered as 2 actuations in each nostril.

Assessment of efficacy was based on the total nasal symptom score (TNSS). TNSS is calculated as the sum of the patients’ scoring of the 4 individual nasal symptoms (rhinorrhea, sneezing, nasal congestion, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective (rTNSS) or instantaneous (iTNSS). rTNSS required the patients to record symptom severity over the previous 12 hours; iTNSS required the patients to record symptom severity over the previous 10 minutes. Morning and evening TNSS scores were averaged over the treatment period and the difference from placebo in the change from baseline rTNSS was the primary efficacy endpoint. The morning iTNSS reflects the TNSS at the end of the 24-hour dosing interval and is an indication of whether the effect was maintained over the 24-hour dosing interval.

Dose-Ranging Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 3 doses of beclomethasone dipropionate nasal aerosol (80, 160, and 320 mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, only treatment with beclomethasone dipropionate nasal aerosol at the dose of 320 mcg/day resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS (Table 3).

Table 3. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 2 Weeks in Adult and Adolescent Patients with Seasonal Allergic Rhinitis (ITT Population)
Treatment N Baseline (SD) LS Mean (SE) Change from Baseline Difference From Placebo
LS Mean 95% CI

Beclomethasone dipropionate

320 mcg/day

122

9.17 (1.66)

-2.22 (0.18)

-0.63

-1.13, 0.13

Beclomethasone dipropionate

160 mcg/day

123

9.24 (1.57)

-1.87 (0.18)

-0.29

-0.78, 0.21

Beclomethasone dipropionate

80 mcg/day

118

9.33 (1.72)

-1.88 (0.18)

-0.29

-0.80, 0.21

Placebo

123

8.98 (1.47)

-1.59 (0.18)

The 320 mcg dose also demonstrated a statistically significant decrease in morning iTNSS than placebo, indicating that the effect was maintained over the 24-hour dosing interval.

Seasonal and Perennial Allergic Rhinitis Trials: In 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trials, once-daily treatment with QNASL Nasal Aerosol for 2 weeks in patients with seasonal allergic rhinitis and for 6 weeks in patients with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS and morning iTNSS than placebo (Table 4).

Table 4. Mean Changes From Baseline in Reflective and Instantaneous Total Nasal Symptom Scores in Adult and Adolescent Patients with Seasonal or Perennial Allergic Rhinitis (ITT Population)
Treatment N Baseline (SD) LS Mean (SE) Change from Baseline Difference From Placebo
LS Mean 95% CI

Seasonal Allergic Rhinitis

Reflective Total Nasal Symptom Scores (rTNSS)

Beclomethasone dipropionate320 mcg/day

167

9.6 (1.51)

-2.0 (0.16)

-0.91

-1.3, -0.5

Placebo

171

9.5 (1.54)

-1.0 (0.15)

Instantaneous Total Nasal Symptom Scores (iTNSS)

Beclomethasone dipropionate320 mcg/day

167

9.0 (1.74)

-1.7 (0.15)

-0.92

-1.3, -0.5

Placebo

171

8.7 (1.81)

-0.8 (0.15)

Perennial Allergic Rhinitis

Reflective Total Nasal Symptom Scores (rTNSS)

Beclomethasone dipropionate320 mcg/day

232

8.9 (1.70)

-2.5 (0.14)

-0.84

-1.2, -0.5

Placebo

234

9.0 (1.73)

-1.6 (0.14)

Instantaneous Total Nasal Symptom Scores (iTNSS)

Beclomethasone dipropionate320 mcg/day

232

8.1 (1.98)

-2.1 (0.13)

-0.78

-1.1, -0.4

Placebo

234

8.3 (1.96)

-1.4 (0.13)

Pediatric Patients 4 to 11 Years of Age: The efficacy and safety of QNASL Nasal Aerosol have been evaluated in 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 12 weeks duration in pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis. The 2 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis (6 — 11 years of age), and one 12-week efficacy trial in patients with perennial allergic rhinitis (4 — 11 years of age). The trials included a total of 1255 patients (680 males and 575 females). About 73% of patients were Caucasian and 20% African American, the mean age was approximately 8 years for one study and 9 years for the second study. Of these patients 596 received QNASL Nasal Aerosol 80 mcg once daily administered as 1 actuation of QNASL 40 mcg Nasal Aerosol in each nostril.

Assessment of efficacy was based on the total nasal symptom score (TNSS) as described in adult and adolescents efficacy studies.

Dose-Ranging Seasonal Allergic Rhinitis Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 2 doses of beclomethasone dipropionate nasal aerosol (80 and 160 mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, treatment with beclomethasone dipropionate nasal aerosol at the dose of 80 mcg/day resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS (Table 5).

Table 5. Mean Changes from Baseline in Reflective and Instantaneous Total Nasal Symptom Scores Over 2 Weeks in Pediatric Patients with Seasonal Allergic Rhinitis (ITT Population)

Treatment

N

Baseline

(SD)

LS Mean (SE)

Change

from Baseline

Difference From Placebo

LS Mean

95% CI

Reflective Total Nasal Symptom Scores (rTNSS)

Beclomethasone dipropionate 80 mcg/day

239

8.9 (1.62)

-1.9 (0.14)

-0.71

-1.1, -0.3

Beclomethasone dipropionate 160 mcg/day

241

9.0 (1.71)

-2.0 (0.14)

-0.76

-1.1, -0.4

Placebo

234

9.0 (1.70)

-1.2 (0.14)

Instantaneous Total Nasal Symptom Scores (iTNSS)

Beclomethasone dipropionate 80 mcg/day

238

8.1 (1.99)

-1.6 (0.13)

-0.63

-1.0, -0.3

Beclomethasone dipropionate 160 mcg/day

241

8.1 (2.13)

-1.7 (0.13)

-0.73

-1.1, -0.4

Placebo

234

8.2 (2.10)

-1.0 (0.13)

The 80 mcg daily dose also demonstrated a statistically significant decrease in morning iTNSS than placebo, indicating that the effect was maintained over the 24-hour dosing interval. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose for pediatric patients 4-11 years of age.

Perennial Allergic Rhinitis Trial: In a randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trial, treatment with QNASL Nasal Aerosol 80 mcg once daily in patients with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS (the primary endpoint) and iTNSS than placebo over the first six weeks of treatment (Table 6).

Table 6. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 6 Weeks in Pediatric Patients 6 to 11 Years of Age with Perennial Allergic Rhinitis (FAS)

Treatment

N

Baseline

(SD)

LS Mean (SE)

Change from

Baseline

Difference From Placebo

LS Mean

95% CI

Reflective Total Nasal Symptom Scores (rTNSS)

Beclomethasone dipropionate 80 mcg/day

296

8.6 (1.56)

-2.26 (0.12)

-0.66

-1.08, -0.24

Placebo

153

8.6 (1.60)

-1.60 (0.17)

Instantaneous Total Nasal Symptom Scores (iTNSS)

Beclomethasone dipropionate 80 mcg/day

296

7.9 (2.05)

-1.98 (0.12)

-0.58

-0.99, -0.18

Placebo

153

7.8 (2.12)

-1.39 (0.17)

FAS=full analysis set

For pediatric patients 4-11 years of age, improvements in average patient-reported rTNSS and iTNSS were also significantly greater in QNASL Nasal Aerosol 80 mcg per day treated patients compared with placebo.

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