NCT01504646 - 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)

Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ
Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29.
Dahlén B, Roquet A, Inman MD, Karlsson O, Naya I, Anstrén G, O'Byrne PM, Dahlén SE
Influence of zafirlukast and loratadine on exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2002 May;109(5):789-93.
Flower RJ, Perretti M
Controlling inflammation: a fat chance? J Exp Med. 2005 Mar 7;201(5):671-4. Review.
Horrocks LA, Yeo YK
Health benefits of docosahexaenoic acid (DHA). Pharmacol Res. 1999 Sep;40(3):211-25. Review.
Mickleborough TD, Lindley MR, Ionescu AA, Fly AD
Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49.
Mickleborough TD, Murray RL, Ionescu AA, Lindley MR
Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. Epub 2003 Aug 6.
Mickleborough TD
A nutritional approach to managing exercise-induced asthma. Exerc Sport Sci Rev. 2008 Jul;36(3):135-44. doi: 10.1097/JES.0b013e31817be827. Review.
Soutar A, Seaton A, Brown K
Bronchial reactivity and dietary antioxidants. Thorax. 1997 Feb;52(2):166-70.

Randomized Controlled Trial of Marine Lipid Fraction PCSO-524™ on Airway Inflammation and Hyperpnea-Induced Bronchoconstriction in Asthma

Clinical trial NCT01504646 - References