NCT02696850 - 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)

Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H
Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. Review.
Browne JP, Hopkins C, Slack R, Cano SJ
The Sino-Nasal Outcome Test (SNOT): can we make it more clinically meaningful? Otolaryngol Head Neck Surg. 2007 May;136(5):736-41.
Piccirillo JF, Merritt MG Jr, Richards ML
Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7.
Report of the Rhinosinusitis Task Force Committee Meeting
Alexandria, Virginia, August 17, 1996. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 2):S1-68. Review.
Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A
The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555.
Snidvongs K, Pratt E, Chin D, Sacks R, Earls P, Harvey RJ
Corticosteroid nasal irrigations after endoscopic sinus surgery in the management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2012 Sep-Oct;2(5):415-21. doi: 10.1002/alr.21047. Epub 2012 May 7.
Steinke JW, Payne SC, Tessier ME, Borish LO, Han JK, Borish LC
Pilot study of budesonide inhalant suspension irrigations for chronic eosinophilic sinusitis. J Allergy Clin Immunol. 2009 Dec;124(6):1352-4.e7. doi: 10.1016/j.jaci.2009.09.018.

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Details for clinical trial NCT02696850

Clinical trial NCT02696850 - References