Asthma and Clinical Challenges in Clinical Trials

• Activity Number: 122
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biometrics Section
• Author(s): Jonathan Goldin*+
• Companies: UCLA Radiology
• Keywords: asthma ; PRO ; imaging ; biomarker ; validation ; clinical trial

Abstract

Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to wheezing, shortness of breath, chest tightness, and coughing. These are the basis of the patient report outcomes (PRO) used to assess patients. Most people with asthma have attacks separated by symptom-free periods. Symptoms also vary during a given day. The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways including spirometry, peak flow and PRO. No single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Because of the challenges associated with conducting clinical trials, not all drugs have been adequately tested. It is important to understand the challenges with collecting PRO, the limitation of spirometry and the role of new imaging techniques.