title: Relapse in FEV1 Decline After Steroid Withdrawal in COPD.
abstract: BACKGROUND
  We previously observed that 30 months of inhaled corticosteroid (ICS) treatment can attenuate FEV1 decline in COPD, but it is unclear whether withdrawal induces a relapse. We hypothesized that FEV1 decline, airway hyperresponsiveness (AHR), and quality of life (QOL) deteriorate after ICS cessation even after prolonged use.
  
  
  METHODS
  One hundred fourteen patients with moderate to severe COPD finished randomized 6-month or 30-month treatment with fluticasone (500 μg bid), 30-month treatment with fluticasone and salmeterol (500/50 μg bid), or placebo (first part of the Groningen and Leiden Universities Corticosteroids in Obstructive Lung Disease [GLUCOLD] study [GL1]). The subsequent 5 years, patients were prospectively followed annually, treated by their physician (GLUCOLD follow-up study [GL2]). Postbronchodilator FEV1, AHR, and QOL were initially recorded at baseline, at 30 months (GL1), and annually during GL2. Analysis was performed by linear mixed-effects models.
  
  
  RESULTS
  Among 101 adherent patients during GL1, 79 patients started and 58 completed GL2. Patients using ICSs during GL1, but only using ICSs 0% to 50% of the time during GL2 (n = 56 of 79), had significantly accelerated annual FEV1 decline compared with GL1 (difference GL2-GL1 [95% CI]: 30-month treatment with fluticasone and salmeterol, -68 mL/y [-112 to -25], P = .002; 30-month treatment with fluticasone, -73 mL/y [-119 to -26], P = .002), accompanied by deterioration in AHR and QOL.
  
  
  CONCLUSIONS
  ICS discontinuation after 30 months in COPD can worsen lung function decline, AHR, and QOL during 5-year follow-up. This suggests that ICS treatment lacks sustained disease-modifying effect after treatment cessation.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00158847; URL: www.clinicaltrials.gov.
authors.affiliation: Department of Pulmonology, LUMC, Leiden, The Netherlands. Electronic address: L.I.Z.Kunz@lumc.nl.
authors.forename: Lisette I Z
authors.initials: LIZ
authors.lastname: Kunz
authors.affiliation: Department of Pulmonary Medicine and Department of Epidemiology, UMCG, University of Groningen, Groningen, The Netherlands.
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
authors.affiliation: Department of Pulmonary Medicine and Department of Epidemiology, UMCG, University of Groningen, Groningen, The Netherlands.
authors.forename: Karin
authors.initials: K
authors.lastname: Klooster
authors.affiliation: Department of Pulmonology, LUMC, Leiden, The Netherlands; Department of Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore.
authors.forename: Thérese S
authors.initials: TS
authors.lastname: Lapperre
authors.affiliation: Department of Pulmonary Medicine and Department of Epidemiology, UMCG, University of Groningen, Groningen, The Netherlands.
authors.forename: Judith M
authors.initials: JM
authors.lastname: Vonk
authors.affiliation: Department of Medical Decision Making, LUMC, Leiden, The Netherlands.
authors.forename: Jacob K
authors.initials: JK
authors.lastname: Sont
authors.affiliation: Department of Pulmonary Medicine and Department of Epidemiology, UMCG, University of Groningen, Groningen, The Netherlands.
authors.forename: Huib A M
authors.initials: HAM
authors.lastname: Kerstjens
authors.affiliation: Department of Medical Decision Making, LUMC, Leiden, The Netherlands.
authors.forename: Jiska B
authors.initials: JB
authors.lastname: Snoeck-Stroband
authors.affiliation: Department of Pulmonology, LUMC, Leiden, The Netherlands.
authors.forename: Pieter S
authors.initials: PS
authors.lastname: Hiemstra
authors.affiliation: Department of Respiratory Medicine, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Sterk
authors.affiliation: Department of Pulmonology, LUMC, Leiden, The Netherlands.
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000280:Administration, Inhalation; D000420:Albuterol / Q000031:analogs & derivatives / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use; D015331:Cohort Studies; D004338:Drug Combinations; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000627:therapeutic use; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy / Q000503:physiopathology; D011788:Quality of Life; D012008:Recurrence; D028761:Withholding Treatment
chemical_list: D000420:Albuterol; D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids