Despite a number of available safe and effective therapies to treat asthma, a high proportion of persons with asthma remain symptomatic and at risk for exacerbations. When the Asthma Working Group was formed in 2012, no standard patient-reported outcome (PRO) measure existed for asthma that was considered adequate for measuring important patient-experienced aspects of the disease. Such a measure could be used in addition to spirometric assessment of lung function in the development of drugs for the treatment of persistent asthma. The Asthma Working Group developed the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) to enable the capture of the core symptoms of asthma in adolescents (12 to 17 years old) and adults (18 years and older) for the assessment of clinical benefit in asthma treatment trials. In March 2019, the ADSD and ANSD were qualified by FDA for use in drug development. The Qualification Statement can be found at FDA’s Clinical Outcome Assessment Qualification Program Qualified Clinical Outcome Assessments (COA) Page. Further information about the ADSD and ANSD and how to license them is available at: https://www.c-pathcoas.org.
Working Group Sponsors
The following firms provided financial support for Asthma Working Group:
Actelion (now part of Janssen Pharmaceutical Companies of Johnson & Johnson)
Allergan (now AbbVie, Inc.)
AstraZeneca Pharmaceuticals LP
Boehringer Ingelheim Pharmaceuticals, Inc.
Janssen Pharmaceutical Companies of Johnson & Johnson
Merck, Sharp & Dohme Corp.
Novartis Pharmaceutical Corporation