ASTEPRO Clinical Study information

The efficacy and safety of ASTEPRO Nasal Spray was evaluated in a 2-week, randomized, multicenter, double-blind, placebo-controlled clinical trial including 834 adult and adolescent patients 12 years of age and older with symptoms of seasonal allergic rhinitis.1 The population was 12 to 83 years of age (60% female, 40% male; 69% white, 16% black, 12% Hispanic, 2% Asian, 1% other).

Patients were randomized to one of six treatment groups: 1 spray per nostril of either ASTEPRO Nasal Spray, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of ASTEPRO Nasal Spray, Astelin Nasal Spray or placebo twice daily.

Assessment of efficacy was based on the 12-hour reflective total nasal symptom score (rTNSS) assessed daily in the morning and evening. TNSS is calculated as the sum of the patients’ scoring of the four individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The rTNSS required patients to record symptom severity over the previous 12 hours. For the primary efficacy endpoint, morning (AM) and evening (PM) rTNSS scores were summed for each day (maximum score of 24) and then averaged over the 14–day treatment period.

The efficacy of ASTEPRO Nasal Spray one spray per nostril twice daily is supported by two, 2-week, placebo-controlled clinical trials with Astelin Nasal Spray in 413 patients with seasonal allergic rhinitis. In these trials, efficacy was assessed using the TNSS (described above). Astelin Nasal Spray demonstrated a greater decrease, from baseline in the summed AM and PM rTNSS compared with placebo and the difference was statistically significant. 1

Rapid Onset

Significant improvement in TNSS in as early as 30 minutes2,3

  • In one placebo-controlled study of 284 SAR patients conducted over 2 weeks, ASTEPRO administered 2 sprays per nostril bid demonstrated an onset of action vs placebo vehicle at 30 minutes and sustained efficacy vs placebo through the end of the 2-week study period.2
  • In a second study of 343 SAR patients conducted over 2 weeks, ASTEPRO administered 2 sprays per nostril bid demonstrated an onset of action vs placebo vehicle at 240 minutes and sustained efficacy vs placebo through the end of the 2-week study period.3

1 ASTEPRO package insert. Somerset, NJ: Meda Pharmaceuticals Inc; 2008.
2 Data on file. Study MP430. Meda Pharmaceuticals Inc.
3 Data on file. Study MP438. Meda Pharmaceuticals Inc.