1. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial
- Author
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Peter Lange, Mark T. Dransfield, Dave Singh, Sally Lettis, Robert A. Wise, David A. Lomas, David M.G. Halpin, Sally Kilbride, Neil R.W. Martin, Gerard J. Criner, C. Elaine Jones, David A. Lipson, Fernando J. Martinez, and MeiLan K. Han
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.drug_class ,Chronic Obstructive Pulmonary Disease ,Pulmonary disease ,Impact study ,Critical Care and Intensive Care Medicine ,Fluticasone propionate ,chronic obstructive pulmonary disease ,Double blind ,03 medical and health sciences ,chemistry.chemical_compound ,Pulmonary Disease, Chronic Obstructive ,0302 clinical medicine ,step down ,Double-Blind Method ,Adrenal Cortex Hormones ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,COPD ,business.industry ,Original Articles ,medicine.disease ,Clinical trial ,030228 respiratory system ,chemistry ,triple therapy ,Corticosteroid ,Vilanterol ,business ,medicine.drug - Abstract
Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization. Methods: Exacerbations and change from baseline in trough FEV1 and St. George’s Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days. Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; P
- Published
- 2020