NCT01091493 - 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)

Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA
Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. Erratum in: Am J Respir Crit Care Med 1997 Jan;155(1):386.
Murray CJ, Lopez AD, Black R, Mathers CD, Shibuya K, Ezzati M, Salomon JA, Michaud CM, Walker N, Vos T
Global burden of disease 2005: call for collaborators. Lancet. 2007 Jul 14;370(9582):109-10.
Snow V, Lascher S, Mottur-Pilson C; Joint Expert Panel on COPD of the American College of Chest Physicians and the American College of Physicians-Amercian Society of Internal Medicine
The evidence base for management of acute exacerbations of COPD: clinical practice guideline, part 1. Chest. 2001 Apr;119(4):1185-9.

Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy

Details for clinical trial NCT01091493

Clinical trial NCT01091493 - References