NCT02056379 - 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)

Geelhoed GC, Macdonald WB
Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol. 1995 Dec;20(6):355-61.
Johnson DW, Jacobson S, Edney PC, Hadfield P, Mundy ME, Schuh S
A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup. N Engl J Med. 1998 Aug 20;339(8):498-503.
Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC
Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9.
Sinha A, Jayashree M, Singhi S
Aerosolized L-epinephrine vs budesonide for post extubation stridor: a randomized controlled trial. Indian Pediatr. 2010 Apr;47(4):317-22. Epub 2009 Sep 3.

Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children

Clinical trial NCT02056379 - References