NCT02079792 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bateman ND, Whymark AD, Clifton NJ, Woolford TJ
A study of intranasal distribution of azelastine hydrochloride aqueous nasal spray with different spray techniques. Clin Otolaryngol Allied Sci. 2002 Oct;27(5):327-30.
Cannady SB, Batra PS, Citardi MJ, Lanza DC
Comparison of delivery of topical medications to the paranasal sinuses via "vertex-to-floor" position and atomizer spray after FESS. Otolaryngol Head Neck Surg. 2005 Nov;133(5):735-40.
Grobler A, Weitzel EK, Buele A, Jardeleza C, Cheong YC, Field J, Wormald PJ
Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope. 2008 Nov;118(11):2078-81. doi: 10.1097/MLG.0b013e31818208c1.
Manes RP, Tong L, Batra PS
Prospective evaluation of aerosol delivery by a powered nasal nebulizer in the cadaver model. Int Forum Allergy Rhinol. 2011 Sep-Oct;1(5):366-71. doi: 10.1002/alr.20057. Epub 2011 May 9.
Singhal D, Weitzel EK, Lin E, Feldt B, Kriete B, McMains KC, Thwin M, Wormald PJ
Effect of head position and surgical dissection on sinus irrigant penetration in cadavers. Laryngoscope. 2010 Dec;120(12):2528-31. doi: 10.1002/lary.21092.
Valentine R, Athanasiadis T, Thwin M, Singhal D, Weitzel EK, Wormald PJ
A prospective controlled trial of pulsed nasal nebulizer in maximally dissected cadavers. Am J Rhinol. 2008 Jul-Aug;22(4):390-4. doi: 10.2500/ajr.2008.22.3191.

The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device: A Randomized, Single-blind, Parallel Trial Comparing the Lying-Head-Back Versus the Head-Down-to-Floor Positions

Details for clinical trial NCT02079792

Clinical trial NCT02079792 - References