Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Severe Unilateral Lung Parenchymal Opacities: A Unique Presentation of Granulomatosis with Polyangiitis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Lung Function Trajectories Leading to Chronic Obstructive Pulmonary Disease as Predictors of Exacerbations and Mortality

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Cardiorespiratory responses to high intensity skeletal muscle metaboreflex activation in chronic obstructive pulmonary disease

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Danish general practitioners' management of patients with COPD: a nationwide survey

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Occupational exposures and exacerbations of asthma and COPD-A general population study

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Beta-blocker use and acute exacerbations of COPD following myocardial infarction: a Danish nationwide cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  • MeiLan K Han
  • Gerard J Criner
  • Mark T Dransfield
  • David M G Halpin
  • C Elaine Jones
  • Sally Kilbride
  • Peter Lange
  • Sally Lettis
  • David A Lipson
  • David A Lomas
  • Neil Martin
  • Robert A Wise
  • Dave Singh
  • Fernando J Martinez
View graph of relations

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 < 0.001), but only a numerical reduction was seen among prior ICS nonusers (12% reduction; P = 0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce the annual on-treatment moderate/severe exacerbation rate (19%; P < 0.001) compared with UMEC/VI. The benefit of FF/UMEC/VI compared with UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users, 35% reduction; P < 0.001; non-ICS users, 35% reduction; P = 0.018), and overall when excluding the first 30 days (29%; P < 0.001). Improvements from baseline with FF/UMEC/VI compared with UMEC/VI were also maintained throughout the study for both trough FEV1 and St. George's Respiratory Questionnaire, regardless of prior ICS use.Conclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.Clinical trial registered with www.clinicaltrials.gov (NCT02164513).

Original languageEnglish
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume202
Issue number9
Pages (from-to)1237-1243
Number of pages7
ISSN1073-449X
DOIs
Publication statusPublished - 1 Nov 2020

    Research areas

  • Administration, Inhalation, Aged, Benzyl Alcohols/administration & dosage, Bronchodilator Agents/administration & dosage, Chlorobenzenes/administration & dosage, Double-Blind Method, Female, Fluticasone/administration & dosage, Humans, Male, Middle Aged, Pulmonary Disease, Chronic Obstructive/drug therapy, Quinuclidines/administration & dosage, Substance Withdrawal Syndrome/physiopathology

ID: 61962697