ZETONNA® (ciclesonide) Nasal Aerosol, a dry formulation with STAYABILITY
- HFA-propelled dry nasal aerosol delivery
- Retention measured in 2 scintigraphy trials
≥ 98% of ciclesonide radiolabeled solution was retained in the nasal cavity12,13
at ≈ 2 minutes postdose
In Trial 112
98% of ciclesonide radiolabeled solution was initially retained in the nasal cavity ≈ 2 minutes postdose
In Trial 213
>99% of ciclesonide radiolabeled solution was retained in the nasal cavity ≈ 2 minutes postdose
- After 10 minutes:
- Retention in the nasal cavity was 81%
- Deposition in the nasopharynx, as determined by the calculated posterior loss of radioactivity from the nasal cavity, was 18%
- Deposition of radioactivity on nasal wipes was 2%
Methods12,13
Open-label, single-dose, single-site, randomized trials that evaluated deposition in the nasal cavity
-Study 1 (N=10); healthy patients
-Study 2 (N=14); patients with symptomatic SAR or PAR
Treatments were modified by adding a radiolabel.
In Trial 1, the primary objective was to quantify the percentage of the delivered dose (ie, the total amount of radioactivity delivered) initially deposited in the nasal cavity and in the lungs, respectively, following nasal inhalation (1-4 minutes).
In Trial 2, the primary objective was to quantify the percentage of the delivered dose (ie, the total amount of radioactivity delivered) initially deposited in the nasal cavity following nasal inhalation.
