PMID- 32341641
OWN - NLM
STAT- MEDLINE
DCOM- 20210625
LR  - 20210625
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 15
DP  - 2020
TI  - The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized 
      Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies.
PG  - 745-754
LID - 10.2147/COPD.S242767 [doi]
AB  - PURPOSE: Rescue medication use is common in chronic obstructive pulmonary 
      disease (COPD) patients and tends to increase with symptoms and disease severity. 
      An analysis of baseline rescue medication use was conducted to inform on patient 
      phenotypes and subsequent effects on lung function, symptoms, and safety 
      following 12 weeks of nebulized glycopyrrolate (GLY) 25 microg twice daily or placebo 
      in patients with moderate-to-very-severe COPD. PATIENTS AND METHODS: Pooled data 
      from the 12-week, placebo-controlled GOLDEN 3 and 4 studies (n=781) were used to 
      assign patients into quarters based on baseline rescue medication use (ie, 
      average puffs-per-day) during the run-in period. Placebo-adjusted trough forced 
      expiratory volume in 1 second (FEV(1)), St. George's Respiratory Questionnaire 
      (SGRQ) total score and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) 
      total score data were reported; safety was evaluated by reviewing the incidence 
      of adverse events (AEs) and serious AEs (SAEs). RESULTS: Baseline rescue 
      medication use was a proxy for disease severity, evidenced by decreased lung 
      function, increased health status scores, symptom scores and use of background 
      long-acting beta2-agonists and inhaled corticosteroids across quarters and treatment 
      groups. Treatment with GLY led to greater improvements from baseline in trough 
      FEV(1), SGRQ and EXACT-RS scores compared with placebo in all rescue medication 
      use quarters. Additionally, the SGRQ and EXACT-RS exhibited greater improvement 
      with increased baseline rescue medication use with GLY treatment. In the Q4 
      patients, SGRQ (>/=4-unit reduction) or EXACT-RS (>/=2-unit reduction) responders 
      were significantly greater with GLY compared with placebo. AE and SAE incidences 
      were similar across quartiles. CONCLUSION: These results suggest that baseline 
      rescue medication use assessments may be useful in the management of COPD. 
      Treatment with nebulized GLY improved lung function and symptom scores, 
      regardless of baseline rescue medication use. These results support the use of 
      nebulized GLY for the treatment of COPD, independent of baseline rescue 
      medication use.
CI  - (c) 2020 Donohue et al.
FAU - Donohue, James F
AU  - Donohue JF
AUID- ORCID: 0000-0002-4439-6866
AD  - Department of Pulmonary Diseases and Critical Care Medicine, University of North 
      Carolina School of Medicine, Chapel Hill, NC, USA.
FAU - Ozol-Godfrey, Ayca
AU  - Ozol-Godfrey A
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
FAU - Goodin, Thomas
AU  - Goodin T
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
FAU - Sanjar, Shahin
AU  - Sanjar S
AUID- ORCID: 0000-0003-1462-436X
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
LA  - eng
PT  - Journal Article
DEP - 20200414
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Muscarinic Antagonists)
RN  - V92SO9WP2I (Glycopyrrolate)
SB  - IM
EIN - Int J Chron Obstruct Pulmon Dis. 2020 May 26;15:1177. PMID: 32581524
MH  - Administration, Inhalation
MH  - Bronchodilator Agents/therapeutic use
MH  - Double-Blind Method
MH  - Forced Expiratory Volume
MH  - *Glycopyrrolate/therapeutic use
MH  - Humans
MH  - Muscarinic Antagonists/therapeutic use
MH  - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug therapy
MH  - Treatment Outcome
PMC - PMC7166066
OTO - NOTNLM
OT  - COPD
OT  - LAMA
OT  - glycopyrrolate
OT  - rescue medication use
COIS- JFD has been an advisor and received personal fees from Sunovion and Mylan, and 
      has served on advisory boards for Theravance. AO-G, TG, and SS are employees of 
      Sunovion Pharmaceuticals, Inc. The authors report no other conflicts of interest 
      in this work.
EDAT- 2020/04/29 06:00
MHDA- 2021/06/29 06:00
PMCR- 2020/04/14
CRDT- 2020/04/29 06:00
PHST- 2019/12/17 00:00 [received]
PHST- 2020/03/30 00:00 [accepted]
PHST- 2020/04/29 06:00 [entrez]
PHST- 2020/04/29 06:00 [pubmed]
PHST- 2021/06/29 06:00 [medline]
PHST- 2020/04/14 00:00 [pmc-release]
AID - 242767 [pii]
AID - 10.2147/COPD.S242767 [doi]
PST - epublish
SO  - Int J Chron Obstruct Pulmon Dis. 2020 Apr 14;15:745-754. doi: 
      10.2147/COPD.S242767. eCollection 2020.