NCT02102152 - 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)

Cochrane review: Prolonged antibiotics for purulent bronchiectasis in children and adults (Review), Evans DJ, Bara A, Greenstone M
The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd. 13 January 2011.
Konstan MW, Flume PA, Kappler M, Chiron R, Higgins M, Brockhaus F, Zhang J, Angyalosi G, He E, Geller DE
Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. J Cyst Fibros. 2011 Jan;10(1):54-61. doi: 10.1016/j.jcf.2010.10.003. Epub 2010 Nov 12.
Scheinberg P, Shore E
A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis. Chest. 2005 Apr;127(4):1420-6.

Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection

Clinical trial NCT02102152 - References