Allergies — The Phthalate-Allergen Immune Response Study
Citation(s)
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Hoppin JA, Ulmer R, London SJ Phthalate exposure and pulmonary function. Environ Health Perspect. 2004 Apr;112(5):571-4.
Jaakkola JJ, Knight TL The role of exposure to phthalates from polyvinyl chloride products in the development of asthma and allergies: a systematic review and meta-analysis. Environ Health Perspect. 2008 Jul;116(7):845-53. doi: 10.1289/ehp.10846. Review.
Kolarik B, Lagercrantz L, Sundell J Nitric oxide in exhaled and aspirated nasal air as an objective measure of human response to indoor air pollution. Indoor Air. 2009 Apr;19(2):145-52. doi: 10.1111/j.1600-0668.2008.00572.x. Epub 2008 Dec 11.
Peters,S , Shaver,J., & Zangrilli,J.G. Airway responses to antigen in asthmatic and nonasthmatic subjects in Inflammatory mechanisms in asthma (eds. Holgate,S.T. & Busse,W.W.) (Marcel Dekker, New York, 2014).
Wittassek M, Koch HM, Angerer J, Brüning T Assessing exposure to phthalates - the human biomonitoring approach. Mol Nutr Food Res. 2011 Jan;55(1):7-31. doi: 10.1002/mnfr.201000121. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
