NCT01405339 - 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)

Bhalla RK, Payton K, Wright ED
Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):821-5.
Kanowitz SJ, Batra PS, Citardi MJ
Topical budesonide via mucosal atomization device in refractory postoperative chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2008 Jul;139(1):131-6. doi: 10.1016/j.otohns.2008.03.009.
Lund VJ, Black JH, Szabó LZ, Schrewelius C, Akerlund A
Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62.
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.
Scott MB, Skoner DP
Short-term and long-term safety of budesonide inhalation suspension in infants and young children with persistent asthma. J Allergy Clin Immunol. 1999 Oct;104(4 Pt 2):200-9.

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

Clinical trial NCT01405339 - References