Are asthmatics enrolled in randomized trials representative of real-life outpatients?

Respiration; International Review of Thoracic Diseases
Salvatore BattagliaNicola Scichilone

Abstract

This study was aimed at exploring to what extent populations enrolled in randomized controlled trials (RCTs) of inhalation combination treatment for mild/moderate asthma in adults are fully representative of 'real-life' populations. The following is a retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of asthma. A retrospective analysis was performed. Stable conditions, such as smoking habit and chronic diseases other than asthma, were identified as exclusion criteria for RCTs. The selected criteria were then applied to asthmatic outpatients, yielding a population that was potentially eligible for RCTs. Out of 1,909 subjects, 824 (43.2%) met at least one of the exclusion criteria for RCTs. Cigarette smoking (occurring in 34.3% of the entire population), lung diseases other than asthma (5.0%), anxiety and depression (3.3%), arrhythmias (2.3%), and coronary artery disease (1.2%) would have been the most frequent causes for exclusion from RCTs. The proportion of patients excluded from RCTs appears to increase with age, reaching 57.1% in patients aged >85 years. In a real-life setting, >40% of subjects with mild/moderate asthma are currently treated by protocols based on the results ...Continue Reading

Citations

Feb 5, 2016·Asia Pacific Allergy·Mi-Yeong KimSang-Heon Cho
Jun 24, 2016·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·Gennaro LiccardiPaola Rogliani
Mar 18, 2016·Expert Review of Clinical Pharmacology·Fabio AgustaNicola Scichilone
Oct 23, 2016·Drugs & Aging·Hoang Kim Tu TrinhHae-Sim Park
Jan 20, 2017·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·M Gerhardsson de VerdierNeil Johnston
Feb 24, 2017·Journal of Managed Care & Specialty Pharmacy·William MalatestinicAndre Araujo
Jan 7, 2017·Respiratory Research·Salvatore Battaglia, Nicola Scichilone
Apr 13, 2017·Clinical and Molecular Allergy : CMA·G SennaUNKNOWN SANI
Nov 11, 2016·Annals of the American Thoracic Society·Gwen S SklootUNKNOWN ATS ad hoc Committee on Asthma in the Elderly
Oct 12, 2018·The Journal of International Medical Research·Zhang Quan-SanSun Zhaojia
Apr 12, 2016·Breathe·Salvatore BattagliaNicola Scichilone
Sep 15, 2019·Thorax·Dominick E ShawAndrew W Fogarty
May 1, 2019·NPJ Primary Care Respiratory Medicine·Mathijs VeenendaalTjard R Schermer
Aug 27, 2016·BMC Pulmonary Medicine·M CaminatiUNKNOWN North East Omalizumab Network study group
Dec 1, 2020·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·Stefania PrincipeNicola Scichilone
Dec 19, 2020·Diabetes, Obesity & Metabolism·Felippe Lazar NetoMilton Arruda Martins
Apr 23, 2021·Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology·Stefania PrincipeAnke H Maitland-van der Zee

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