Persistent Asthma Paper

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Title of article is A Study of Safety and Efficacy of CNTO 148 in Patients with Severe Persistent Asthma (ClinicalTrials.gov, 2013). The official title is A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects with Severe Persistent Asthma.
a. Purpose of the study
The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma. This is a multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive …show more content…

Patient inclusion criteria
• Physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year to screening
• Continuous treatment with high dose Inhaled corticosteroids (ICS) and long acting beta-agonist for at least 3 months prior to screening
• Have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (FEV1) postbronchodilator; Diurnal variation in peak expiratory flow rate (PEFR) greater than or equal to 30 percentage change) and airway hyperresponsiveness
• Estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (e.g., wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ICS and long-acting ß2-agonist (LABA) with or without continuous oral …show more content…

Disadvantages is anaphylaxis. “Subcutaneous allergen immunotherapy, the oldest biologic agent in current use, has the highest of frequency of the most serious and life-threatening reaction, anaphylaxis. It is also one of the only disease modifying interventions for allergic rhinitis and asthma” (Cox, 2009).
f. Your opinion on the research value of this study to advance patient care.
Golimumab was used on 309 patients with asthma. Monthly SC injections of either placebo or golimumab at 50, 100, or 200 mg doses were administered through week 52. Efficacy was assessed from the change from baseline in the prebronchodilator percent-predicted forced expiratory volume 1 (FEV1) and the number of severe exacerbations at week 24. However, no significant changes were observed in these measures, and the agent was found to have an unfavorable risk-benefit profile in this patient population (Mazumdar & Greenwald,

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