PMID- 18694544
OWN - NLM
STAT- MEDLINE
DCOM- 20090417
LR  - 20220309
IS  - 1088-5412 (Print)
IS  - 1088-5412 (Linking)
VI  - 29
IP  - 5
DP  - 2008 Sep-Oct
TI  - Long-term safety and asthma control with budesonide/formoterol versus budesonide 
      pressurized metered-dose inhaler in asthma patients.
PG  - 499-516
LID - 10.2500/aap.2008.29.3147 [doi]
AB  - Safety concerns have been raised regarding the regular use of long-acting 
      beta(2)-adrenergic agonists (LABAs) alone or with inhaled corticosteroids (ICSs). 
      The purpose of this study was to examine the long-term safety of 
      budesonide/formoterol pressurized metered-dose inhaler (pMDI). This 52-week, 
      double-blind study (SD-039-0728; n=708) included patients >or=12 years of age 
      with moderate to severe persistent asthma previously receiving ICSs. After 2 
      weeks on budesonide pMDI 320 microg twice daily (b.i.d.), patients were 
      randomized 3:1:1 overall to budesonide/formoterol pMDI 640/18 microg b.i.d., 
      budesonide/formoterol pMDI 320/9 microg b.i.d., or budesonide pMDI 640 microg 
      b.i.d. The incidence of adverse events (AEs) was similar across the groups. 
      Drug-related AEs (>or=2% overall) were oral candidiasis, tremor, and 
      pharyngolaryngeal pain. No clinically meaningful differences in laboratory, 
      electrocardiogram, or Holter monitor variables were observed. The percentage of 
      patients with >or=1 asthma exacerbation was significantly lower (p=0.006) with 
      budesonide/formoterol 640/18 (12.2%) and numerically lower with 
      budesonide/formoterol 320/9 (14.4%) versus budesonide (21.8%). The number of 
      asthma exacerbations per patient-treatment year was lower with 
      budesonide/formoterol 640/18 (0.174; p=0.004) and budesonide/formoterol 320/9 
      (0.185; p=0.049) versus budesonide (0.315). Improvements in forced expiratory 
      volume in 1 second and diary variables were significantly greater (p<0.001) with 
      both budesonide/formoterol doses versus budesonide. Budesonide/formoterol 640/18 
      and 320/9 microg b.i.d. showed an acceptable safety profile relative to 
      budesonide, with no significant or unexpected patterns of abnormalities observed 
      by adding a LABA to budesonide for up to 1 year in this patient population. 
      Improvements in asthma control were shown with both doses of 
      budesonide/formoterol versus budesonide.
FAU - Peters, Stephen P
AU  - Peters SP
AD  - Section on Pulmonary and Critical Care Medicine, Wake Forest University School of 
      Medicine, Winston-Salem, North Carolina 27157, USA. sppeters@wfubmc.edu
FAU - Prenner, Bruce M
AU  - Prenner BM
FAU - Mezzanotte, William S
AU  - Mezzanotte WS
FAU - Martin, Paula
AU  - Martin P
FAU - O'Brien, Christopher D
AU  - O'Brien CD
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080808
PL  - United States
TA  - Allergy Asthma Proc
JT  - Allergy and asthma proceedings
JID - 9603640
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Ethanolamines)
RN  - 51333-22-3 (Budesonide)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Asthma/*drug therapy
MH  - Bronchodilator Agents/*administration & dosage/adverse effects
MH  - Budesonide/*administration & dosage/adverse effects
MH  - Child
MH  - Double-Blind Method
MH  - Ethanolamines/*administration & dosage/adverse effects
MH  - Female
MH  - Formoterol Fumarate
MH  - Humans
MH  - Male
MH  - Metered Dose Inhalers/adverse effects
MH  - Middle Aged
MH  - Safety
EDAT- 2008/08/13 09:00
MHDA- 2009/04/18 09:00
CRDT- 2008/08/13 09:00
PHST- 2008/08/13 09:00 [pubmed]
PHST- 2009/04/18 09:00 [medline]
PHST- 2008/08/13 09:00 [entrez]
AID - 3147 [pii]
AID - 10.2500/aap.2008.29.3147 [doi]
PST - ppublish
SO  - Allergy Asthma Proc. 2008 Sep-Oct;29(5):499-516. doi: 10.2500/aap.2008.29.3147. 
      Epub 2008 Aug 8.