PMID- 33880019
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20220531
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 16
DP  - 2021
TI  - Effect of SGRQ-Defined Chronic Bronchitis at Baseline on Treatment Outcomes in 
      Patients with COPD Receiving Nebulized Glycopyrrolate.
PG  - 945-955
LID - 10.2147/COPD.S304182 [doi]
AB  - BACKGROUND: Chronic bronchitis (CB) is one of the conditions that contribute to 
      chronic obstructive pulmonary disease (COPD). Despite its widespread prevalence 
      among patients with COPD and overall negative impact on treatment outcomes, the 
      effect of CB on the efficacy of bronchodilator therapy has not been evaluated. 
      The objective of this post hoc analysis is to assess the effect of nebulized 
      glycopyrrolate (GLY) on lung function and health-related quality of life outcomes 
      in patients with St George's Respiratory Questionnaire (SGRQ)-defined CB at 
      baseline. METHODS: Pooled data from the replicate, 12-week GOLDEN 3 and 4 studies 
      (N=861) were grouped by CB status at baseline. The endpoints reported are changes 
      from baseline in trough forced expiratory volume in 1 second (FEV(1)), SGRQ and 
      EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (EXACT-RS) 
      scores. Safety of GLY was evaluated by monitoring the incidence of adverse events 
      (AEs). RESULTS: Following 12 weeks of treatment, GLY 25 mug twice-daily (BID) 
      resulted in placebo-adjusted improvements from baseline in FEV(1) of 77.1 mL and 
      124.4 mL in the CB and non-CB groups, respectively (p<0.0001 vs placebo in both 
      groups). Significant improvements in SGRQ total scores were observed with GLY 25 
      mug BID compared with placebo, regardless of baseline CB status. Although EXACT-RS 
      improvements were noted in both CB and non-CB groups, significant improvements 
      were observed only in the CB group. GLY 25 mug BID was generally well tolerated 
      through 12 weeks of treatment, with a low incidence of AEs. CONCLUSION: Treatment 
      with nebulized GLY 25 mug BID for 12 weeks resulted in significant improvements in 
      lung function and SGRQ total scores, compared with placebo. Significant 
      improvements in EXACT-RS total scores were observed only in the CB group. 
      Together, these results support the use of GLY 25 mug BID in patients with COPD, 
      regardless of their CB status.
CI  - (c) 2021 Tashkin et al.
FAU - Tashkin, Donald P
AU  - Tashkin DP
AD  - Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine 
      at UCLA Health Sciences, Los Angeles, CA, USA.
FAU - Ozol-Godfrey, Ayca
AU  - Ozol-Godfrey A
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
FAU - Sharma, Sanjay
AU  - Sharma S
AUID- ORCID: 0000-0001-5232-3272
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
PT  - Meta-Analysis
DEP - 20210412
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
MH  - *Bronchitis, Chronic/diagnosis/drug therapy
MH  - Bronchodilator Agents/therapeutic use
MH  - Forced Expiratory Volume
MH  - Glycopyrrolate/therapeutic use
MH  - Humans
MH  - Muscarinic Antagonists/therapeutic use
MH  - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug therapy
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
PMC - PMC8051958
OTO - NOTNLM
OT  - COPD
OT  - LAMA
OT  - chronic bronchitis
OT  - nebulized glycopyrrolate
COIS- DPT declares that he has served as a consultant and speaker for Sunovion, 
      AstraZeneca, Innoviva/Theravance, Mylan, and Boehringer-Ingelheim. AOG was an 
      employee of Sunovion Pharmaceuticals Inc at the time of the study and is 
      currently an employee of Alexion Pharmaceuticals. SSh and SSa are employees of 
      Sunovion Pharmaceuticals Inc. The authors report no other conflicts of interest 
      in this work.
EDAT- 2021/04/22 06:00
MHDA- 2021/07/28 06:00
PMCR- 2021/04/12
CRDT- 2021/04/21 06:40
PHST- 2021/01/28 00:00 [received]
PHST- 2021/03/21 00:00 [accepted]
PHST- 2021/04/21 06:40 [entrez]
PHST- 2021/04/22 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
PHST- 2021/04/12 00:00 [pmc-release]
AID - 304182 [pii]
AID - 10.2147/COPD.S304182 [doi]
PST - epublish
SO  - Int J Chron Obstruct Pulmon Dis. 2021 Apr 12;16:945-955. doi: 
      10.2147/COPD.S304182. eCollection 2021.