Journal Article

Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data

Ting, Naitee, Mannino, David, Leidy, Nancy, Clerisme-Beaty, Emmanuelle, Franceschina, Joanne

2018

Overview

Little is known about the recovery patterns from acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in newly diagnosed or maintenance treatment-naïve patients with COPD. This study describes the course of AECOPD in these patients at the time of treatment for the symptoms of acute respiratory tract infection (RTI). This study was a secondary analysis of data from a 12-week, randomized clinical trial (TICARI 1) testing the efficacy and safety of once-daily tiotropium 18 µg maintenance therapy versus placebo in newly diagnosed or maintenance treatment-naïve COPD patients with acute RTI symptoms for ≤7 days. Patients received standard care for AECOPD and RTI. Due to under-recruitment, the trial ended early and hence was underpowered to detect treatment differences. Data were pooled and exacerbation recovery patterns examined by using the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), forced expiratory volume in 1 second, rescue medication use, COPD Assessment Test™, Functional Assessment of Chronic Illness Therapy-Short Form, and Work Productivity and Activity Impairment Questionnaire: Respiratory Symptoms. Of 140 patients, 73.6% had a prior COPD diagnosis without maintenance therapy; 80.0% had moderate-to-severe airflow obstruction. In addition to study drug, 40.0% were prescribed pharmacologic therapy (corticosteroids [34.3%], antibiotics [16.4%], and short-acting β -adrenergic agonists [5.0%]) within ±7 days of randomization. Over 12 weeks, 78.6% exhibited symptomatic recovery (EXACT score) in a median of 5.0 days. Across all patients, 49.3% recovered without relapse, 29.3% recovered and then relapsed, and 21.4% had persistent symptoms (recovery criteria unmet). A substantial portion of newly diagnosed or maintenance treatment-naïve patients with COPD experience relapse or persistent symptoms following a clinic visit for AECOPD with symptoms of RTI. Whether initiating maintenance therapy could improve outcomes and reduce exacerbation risk requires further study.

• Publisher: Dove Medical Press Limited,Dove Medical Press Ltd,Dove Press,Dove Medical Press
• Subject: acute exacerbation of chronic obstructive pulmonary disease / acute exacerbation of chronic obstructive pulmonary disease (AECOPD) / acute respiratory tract infection symptoms / Adrenergic agonists / AECOPD / Analysis / Antibiotics / Asthma / Care and treatment / Chronic diseases / Chronic obstructive lung disease / Chronic obstructive pulmonary disease / Clinical trials / COPD Assessment Test / Corticosteroid drugs / Dyspnea / EXACT / Health aspects / Infection / Infections / Lung diseases / maintenance therapy / Medical research / Original Research / Patient compliance / Patients / Production management / pulmonary function / Respiratory symptoms / Spirometry / Steroids / Steroids (Organic compounds) / Tiotropium