Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial

Randall W. Brown, Christopher D. O'Brien, Ubaldo J. Martin, Tom Uryniak, Kathy L. Lampl

Research output: Contribution to journalArticle

Abstract

Background: Information surrounding the long-term safety of combination inhaled corticosteroid/long-acting β 2-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.

Original languageEnglish (US)
JournalThe Journal of Allergy and Clinical Immunology
Volume130
Issue number2
DOIs
StatePublished - Aug 2012
Externally publishedYes

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Metered Dose Inhalers
Budesonide
African Americans
Asthma
Randomized Controlled Trials
Safety
Formoterol Fumarate
Adrenal Cortex Hormones
Nasopharyngitis
Adrenergic Agonists
Ambulatory Electrocardiography
Sinusitis
Incidence

Keywords

  • African American
  • asthma
  • Budesonide
  • formoterol
  • randomized controlled trial
  • safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients : A randomized controlled trial. / Brown, Randall W.; O'Brien, Christopher D.; Martin, Ubaldo J.; Uryniak, Tom; Lampl, Kathy L.

In: The Journal of Allergy and Clinical Immunology, Vol. 130, No. 2, 08.2012.

Research output: Contribution to journalArticle

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abstract = "Background: Information surrounding the long-term safety of combination inhaled corticosteroid/long-acting β 2-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.",
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