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Genetic variation may differentially modify drug and placebo treatment effects in randomized trials (RCTs). In asthma, although lung function and asthma control improvements are commonplace with placebo, pharmacogenomics of placebo versus drug response remains unexamined. In a GWAS of subjective and objective outcomes with placebo treatment in Childhood Asthma Management Program (CAMP) of nedocromil/budesonide versus placebo (N=604), effect estimates for lead SNPs were compared across arms. The coughing/wheezing lead SNP, rs2392165 (β=0.94; P=1.10E-07) mapped to BBS9, a gene implicated in lung development which contains a lung function expression quantitative trait locus (eQTL). The effect was attenuated with budesonide (P =1.48E-07), but not nedocromil (P =0.06). The lead FVC SNP, rs12930749 (β=-5.80; P=1.47E-06), mapped to KIAA0556, a locus genome-wide associated with respiratory diseases. The rs12930749 effect was attenuated with budesonide (P =1.32E-02) and nedocromil (P =1.09E-02). Pharmacogenomic analysis revealed differential effects with placebo and drug treatment that could potentially guide precision drug development in asthma.
This article was published in the following journal.
Name: Clinical pharmacology and therapeutics
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Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.
Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.
Clinical study in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...