drugset / Trial / NCT01401465

Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray

NCT01401465 ↗

Phase 3 Completed 327 enrolled Sumitomo Pharma America, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to measure patient satisfaction with and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis (AR), is utilized in this study.

Timeline

Start
2011-07
Primary completion
2011-11
Completion
2011-11

Outcome

Met primary endpoint

paper A total of 68.1% of subjects preferred CIC-HFA (p < 0.0001 versus MFNS), with a mean TPS of 68.3 versus 31.7 for the MFNS group. PMID 24169063 ↗

paper The regimen attributes composite satisfaction score significantly (p < 0.0001 for each treatment period) favored CIC-HFA versus MFNS PMID 24169063 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciclesonide Other / unclassified 74 ug Intranasal
Comparator Mometasone Other / unclassified 200 ug Intranasal