Allergic Rhinitis (AR) Clinical Trial
Official title:
A Phase 1, Open Label, Two Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution Following Nasal Inhalation of a Novel Nasal Metered Dose Inhaler (MDI) and of a Mometasone Furoate Monohydrate Radiolabeled Suspension Via an Aqueous (AQ) Nasal Spray
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.
This study is an open label, single dose, single site, randomized, cross over study that
will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide
radiolabeled solution via a novel nasal MDI and of a mometasone furoate monohydrate
radiolabeled suspension via an aqueous nasal spray in approximately 10 14 patients with
symptomatic allergic rhinitis, aged 18 65 years. In order to ensure that patients will be
symptomatic at the time of dosing, participants will be asked to withhold their usual
treatments for perennial or seasonal allergic rhinitis, beginning at the Screening Visit
until after Study Visit 3.
Each patient will be randomly assigned to one of two treatment sequences. The two treatments
in this study are a single dose (one 37 mcg actuation per nostril) of radiolabeled solution
of ciclesonide nasal aerosol 74 µg (Regimen A) and a single dose (two 50 mcg actuations per
nostril) of a radiolabeled suspension of mometasone aqueous nasal spray 200 µg (Regimen B).
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Completed |
NCT02470845 -
Trial of Tian Jiu Therapy for Allergic Rhinitis
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N/A |