PMID- 19953349
OWN - NLM
STAT- MEDLINE
DCOM- 20100323
LR  - 20151119
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 26
IP  - 11
DP  - 2009 Nov
TI  - Nebulized formoterol provides added benefits to tiotropium treatment in chronic 
      obstructive pulmonary disease.
PG  - 1024-34
LID - 10.1007/s12325-009-0080-z [doi]
AB  - INTRODUCTION: The use of one or more long-acting bronchodilators is key in the 
      maintenance therapy of chronic obstructive pulmonary disease (COPD). This 
      analysis pooled the results of two double-blind studies evaluating the efficacy 
      and safety of adding nebulized formoterol fumarate inhalation solution (FFIS) to 
      maintenance tiotropium (TIO) treatment. METHODS: Following a run-in period of 
      7-14 days with once-daily TIO 18 microg, COPD subjects (> or =25% to <65% 
      predicted forced expiratory volume in 1 second [FEV(1)]) were randomized to 
      twice-daily FFIS 20 microg (n=145) or nebulized placebo (PLA, n=140) while 
      continuing on maintenance TIO for 6 weeks. Efficacy was measured using serial 
      spirometry, transition dyspnea index (TDI), rescue albuterol use, and St. 
      George's Respiratory Questionnaire (SGRQ). RESULTS: The mean standardized area 
      under the curve for FEV(1) over 3 hours (FEV(1)AUC(0-3)), the primary efficacy 
      variable, was significantly higher in the FFIS/TIO group than the PLA/TIO group 
      on day 1 (140 mL difference, P<0.0001) and week 6 (192 mL difference, P<0.0001). 
      Mean TDI scores in the FFIS/TIO and PLA/TIO groups were 1.97 and 0.67, 
      respectively (P=0.0001). Mean albuterol use declined in the FFIS/TIO group from 
      2.6 to 1.5 puffs/day compared with little change in the PLA/TIO group (P<0.0001). 
      SGRQ scores were similar between treatment groups with the exception of the 
      symptoms score, which improved in the FFIS/TIO group (-5.8) compared with PLA/TIO 
      (-1.0), and more FFIS/TIO-treated subjects experienced a clinically significant 
      improvement in total SGRQ score. More PLA/TIO-treated subjects than 
      FFIS/TIO-treated subjects experienced adverse events (AEs) (45.7% vs. 31.0%) and 
      COPD exacerbations (7.9% vs. 3.4%). CONCLUSIONS: The addition of FFIS to 
      maintenance TIO treatment for moderate to severe COPD results in significantly 
      improved FEV(1) and dyspnea, decreased rescue medication use, and a lower 
      incidence of AEs and COPD exacerbations. The addition of FFIS to TIO yields 
      clinically and statistically significant benefits for COPD patients and might be 
      of long-term benefit.
FAU - Tashkin, Donald P
AU  - Tashkin DP
AD  - David Geffen School of Medicine at UCLA, Los Angeles, California 90095, USA. 
      dtashkin@mednet.ucla.edu
FAU - Hanania, Nicola A
AU  - Hanania NA
FAU - McGinty, Joe
AU  - McGinty J
FAU - Denis-Mize, Kimberly
AU  - Denis-Mize K
FAU - Chaudry, Imtiaz
AU  - Chaudry I
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20091202
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Ethanolamines)
RN  - 0 (Scopolamine Derivatives)
RN  - QF8SVZ843E (Albuterol)
RN  - W34SHF8J2K (Formoterol Fumarate)
RN  - XX112XZP0J (Tiotropium Bromide)
MH  - Aged
MH  - Albuterol/administration & dosage
MH  - Bronchodilator Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Dyspnea/drug therapy
MH  - Ethanolamines/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Formoterol Fumarate
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nebulizers and Vaporizers
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Respiratory Function Tests
MH  - Scopolamine Derivatives/administration & dosage/*therapeutic use
MH  - Tiotropium Bromide
EDAT- 2009/12/03 06:00
MHDA- 2010/03/24 06:00
CRDT- 2009/12/03 06:00
PHST- 2009/09/29 00:00 [received]
PHST- 2009/12/03 06:00 [entrez]
PHST- 2009/12/03 06:00 [pubmed]
PHST- 2010/03/24 06:00 [medline]
AID - 10.1007/s12325-009-0080-z [doi]
PST - ppublish
SO  - Adv Ther. 2009 Nov;26(11):1024-34. doi: 10.1007/s12325-009-0080-z. Epub 2009 Dec 
      2.