CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Mucosal Atomization Device (MAD) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01405339
NCT01405339Phase 2Completed

The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis

St. Paul's Hospital, Canada·interventional·Posted Jul 29, 2011·Updated Mar 10, 2014

In Brief

A Phase 2 clinical trial evaluating Mucosal Atomization Device (MAD) and Budesonide via Nasal Syringe for Chronic Rhinosinusitis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is believed that the MAD is a better device than the standard nasal lavage because its fine mist enhances absorption and improves bioavailability. No studies have been done to determine if enhanced absorption and improved bioavailability of budesonide via MAD could potentially affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the suppression of our own body's production of natural steroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2011
Enrollment StartAug 1, 2011
Primary CompletionMay 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.9 years ago

Interventions

Mucosal Atomization Device (MAD)device

The use of pulmicort via MAD once a day for a total of 30 days.

Budesonide via Nasal Syringedevice

The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.