Time to COPD Exacerbation in the TONADO® Studies by Disease Severity (Global Initiative for Chronic Obstructive Lung Disease) and Baseline ICS
AAPA ePoster library. Bizik B. 05/17/17; 180507; 125
Brian Bizik
Brian Bizik
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Abstract
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Purpose: Exacerbations lead to reduced lung function and reduced health-related quality of life (HRQoL), contributing to the spiral of disease in chronic obstructive pulmonary disease (COPD).1 Reducing exacerbations is a key goal of COPD treatment due to their detrimental effects on lung function and health status. In the pivotal Phase III TONADO® studies, once-daily tiotropium/olodaterol demonstrated significant improvements in lung function and HRQoL versus the monocomponents over 1 year in patients with moderate-to-very-severe airflow limitation.2 These studies were not designed to compare the effects of tiotropium/olodaterol versus the monocomponents on exacerbation frequency. However, numerically fewer exacerbations occurred overall with tiotropium/olodaterol 2.5/5 and 5/5 µg versus tiotropium or olodaterol alone.3 The >5000 patients in the TONADO® studies provide a large cohort to investigate potential prognostic risk factors for exacerbations, which could help identify patients requiring closer monitoring. This analysis investigated the impact of COPD severity by Global initiative for chronic Obstructive Lung Disease (GOLD) stage on exacerbation risk, as increasing airflow limitation severity is an independent predictor of increased exacerbation risk.4 Inhaled corticosteroid (ICS) use at baseline was also included as a measure of COPD severity because current GOLD guidelines state ICS-containing regimens should only be used in patients with severe COPD at increased risk of exacerbations.1 Methodology: TONADO® 1 and 2 (1237.5, NCT01431274; 1237.6, NCT01431287) were replicate, 52-week, double-blind, multicenter, randomized, active-controlled, five-arm, parallel-group studies. Patients received once-daily tiotropium/olodaterol 2.5/5 or 5/5 µg, tiotropium 2.5 or 5 µg, or olodaterol 5 µg, via the Respimat® inhaler. Patients continued to take ICS if prescribed at baseline but were not permitted to take long-acting β2-agonists, short-acting muscarinic antagonists, or long-acting muscarinic antagonists (other than study medication) during the treatment periods. Short-acting β2-agonists were provided as rescue medication. Time to first moderate or severe exacerbation was analyzed using pooled data from the two studies. COPD exacerbations were defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD, with a duration of >3 days, requiring a change in treatment. For this analysis, qualifying exacerbation ev...
Purpose: Exacerbations lead to reduced lung function and reduced health-related quality of life (HRQoL), contributing to the spiral of disease in chronic obstructive pulmonary disease (COPD).1 Reducing exacerbations is a key goal of COPD treatment due to their detrimental effects on lung function and health status. In the pivotal Phase III TONADO® studies, once-daily tiotropium/olodaterol demonstrated significant improvements in lung function and HRQoL versus the monocomponents over 1 year in patients with moderate-to-very-severe airflow limitation.2 These studies were not designed to compare the effects of tiotropium/olodaterol versus the monocomponents on exacerbation frequency. However, numerically fewer exacerbations occurred overall with tiotropium/olodaterol 2.5/5 and 5/5 µg versus tiotropium or olodaterol alone.3 The >5000 patients in the TONADO® studies provide a large cohort to investigate potential prognostic risk factors for exacerbations, which could help identify patients requiring closer monitoring. This analysis investigated the impact of COPD severity by Global initiative for chronic Obstructive Lung Disease (GOLD) stage on exacerbation risk, as increasing airflow limitation severity is an independent predictor of increased exacerbation risk.4 Inhaled corticosteroid (ICS) use at baseline was also included as a measure of COPD severity because current GOLD guidelines state ICS-containing regimens should only be used in patients with severe COPD at increased risk of exacerbations.1 Methodology: TONADO® 1 and 2 (1237.5, NCT01431274; 1237.6, NCT01431287) were replicate, 52-week, double-blind, multicenter, randomized, active-controlled, five-arm, parallel-group studies. Patients received once-daily tiotropium/olodaterol 2.5/5 or 5/5 µg, tiotropium 2.5 or 5 µg, or olodaterol 5 µg, via the Respimat® inhaler. Patients continued to take ICS if prescribed at baseline but were not permitted to take long-acting β2-agonists, short-acting muscarinic antagonists, or long-acting muscarinic antagonists (other than study medication) during the treatment periods. Short-acting β2-agonists were provided as rescue medication. Time to first moderate or severe exacerbation was analyzed using pooled data from the two studies. COPD exacerbations were defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD, with a duration of >3 days, requiring a change in treatment. For this analysis, qualifying exacerbation ev...
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