TY - JOUR
T1 - Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients
T2 - A randomized controlled trial
AU - Brown, Randall W.
AU - O'Brien, Christopher D.
AU - Martin, Ubaldo J.
AU - Uryniak, Tom
AU - Lampl, Kathy L.
N1 - Funding Information:
Supported by AstraZeneca, LP , Wilmington, Delaware.
Funding Information:
We thank Sarita Shaevitz, PhD, and Cynthia Gobbel, PhD, from Scientific Connexions (Newtown, Pa) for writing assistance funded by AstraZeneca LP .
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2012/8
Y1 - 2012/8
N2 - Background: Information surrounding the long-term safety of combination inhaled corticosteroid/long-acting β2-adrenergic agonist medications in African American asthmatic patients is limited. Objective: We sought to assess safety and asthma control with a budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide over 1 year in African American patients. Methods: This 52-week, randomized, double-blind, parallel-group, multicenter, phase 3B safety study (NCT00419952) was conducted in 742 self-reported African American patients 12 years or older with moderate-to-severe asthma previously receiving medium- to high-dose inhaled corticosteroids. After 2 weeks using a 320 μg twice-daily budesonide pMDI, patients were randomized 1:1 to 320/9 μg twice-daily budesonide/formoterol pMDI or 320 μg twice-daily budesonide pMDI. Results: Both treatments were well tolerated. Asthma exacerbation incidence and rate (per patient-treatment year) were lower with budesonide/formoterol versus budesonide (incidence, 7.7% vs 14.0% [P =.006]; rate ratio, 0.615 [P = .002]). Time to first asthma exacerbation was longer (P =.018) with budesonide/formoterol versus budesonide. The most common adverse events, regardless of study drug relationship, were headache (9.5% and 7.7%), nasopharyngitis (6.9% and 8.0%), sinusitis (4.0% and 6.3%), and viral upper respiratory tract infection (5.8% and 4.4%) for budesonide/formoterol and budesonide, respectively. Serious adverse events occurred in 12 and 15 patients, respectively; none were considered drug related. No substantial or unexpected patterns of abnormalities were observed in laboratory, electrocardiographic, or Holter monitoring assessments. Hospitalization caused by asthma exacerbation occurred in 0 and 4 patients in the budesonide/formoterol and budesonide groups, respectively. Pulmonary function and asthma control measures generally favored budesonide/formoterol. Conclusions: In this population budesonide/formoterol pMDI was well tolerated over 12 months, with a safety profile similar to that of budesonide; the asthma exacerbation rate was reduced by 38.5% versus budesonide.
AB - Background: Information surrounding the long-term safety of combination inhaled corticosteroid/long-acting β2-adrenergic agonist medications in African American asthmatic patients is limited. Objective: We sought to assess safety and asthma control with a budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide over 1 year in African American patients. Methods: This 52-week, randomized, double-blind, parallel-group, multicenter, phase 3B safety study (NCT00419952) was conducted in 742 self-reported African American patients 12 years or older with moderate-to-severe asthma previously receiving medium- to high-dose inhaled corticosteroids. After 2 weeks using a 320 μg twice-daily budesonide pMDI, patients were randomized 1:1 to 320/9 μg twice-daily budesonide/formoterol pMDI or 320 μg twice-daily budesonide pMDI. Results: Both treatments were well tolerated. Asthma exacerbation incidence and rate (per patient-treatment year) were lower with budesonide/formoterol versus budesonide (incidence, 7.7% vs 14.0% [P =.006]; rate ratio, 0.615 [P = .002]). Time to first asthma exacerbation was longer (P =.018) with budesonide/formoterol versus budesonide. The most common adverse events, regardless of study drug relationship, were headache (9.5% and 7.7%), nasopharyngitis (6.9% and 8.0%), sinusitis (4.0% and 6.3%), and viral upper respiratory tract infection (5.8% and 4.4%) for budesonide/formoterol and budesonide, respectively. Serious adverse events occurred in 12 and 15 patients, respectively; none were considered drug related. No substantial or unexpected patterns of abnormalities were observed in laboratory, electrocardiographic, or Holter monitoring assessments. Hospitalization caused by asthma exacerbation occurred in 0 and 4 patients in the budesonide/formoterol and budesonide groups, respectively. Pulmonary function and asthma control measures generally favored budesonide/formoterol. Conclusions: In this population budesonide/formoterol pMDI was well tolerated over 12 months, with a safety profile similar to that of budesonide; the asthma exacerbation rate was reduced by 38.5% versus budesonide.
KW - African American
KW - Budesonide
KW - asthma
KW - formoterol
KW - randomized controlled trial
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=84864470379&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84864470379&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2012.03.028
DO - 10.1016/j.jaci.2012.03.028
M3 - Article
C2 - 22541245
AN - SCOPUS:84864470379
SN - 0091-6749
VL - 130
SP - 362-367.e9
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 2
ER -