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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Zangrilli, James Mansfield, Lyndon E. Uryniak, Tom O'Brien, Christopher D. |
| Description | Country affiliation: United States Author Affiliation: Zangrilli J ( AstraZeneca LP, Wilmington, Delaware, USA.) |
| Abstract | BACKGROUND: Few clinical trials in asthma have focused on Hispanic populations. OBJECTIVE: To compare the efficacy and safety of budesonide/formoterol (BUD/FM) with BUD in an ethnically diverse group of Hispanic participants with asthma previously treated with inhaled corticosteroids (ICS). METHODS: This 12-week, randomized, double-blind, active-controlled study (NCT00419757) was designed to enroll Hispanic participants (self-reported) (≥12 years of age) with moderate to severe asthma requiring medium- to high-dose ICS. After a 2-week run-in period (low-dose BUD pressurized metered-dose inhaler [pMDI] 80 µg × 2 inhalations [160 µg] twice daily), participants with a symptom score greater than 0 (scale: 0-3) on 3 or more of 7 run-in days and forced expiratory volume in 1 second (FEV(1)) 45%-85% predicted were randomized to BUD/FM pMDI 160/4.5 µg × 2 inhalations (320/9 µg) twice daily or BUD pMDI 160 µg × 2 inhalations (320 µg) twice daily. RESULTS: Randomized participants (n = 127 BUD/FM; n = 123 BUD) were predominately Mexican (51%) or Puerto Rican (21%). During low-dose ICS run-in, the mean symptom score was 1.0; however, mean predose FEV(1) improved (2.10-2.21 L). During randomized treatment, small, but not statistically significant, improvements favored BUD/FM vs BUD (am peak expiratory flow [PEF; primary efficacy variable] 25.4 vs 19.9 L/min; pm PEF 20.6 vs 15.8 L/min; predose FEV(1) 0.16 vs 0.11 L; rescue medication use -0.7 vs -0.6 inhalations/d). Most adverse events were mild or moderate in intensity. CONCLUSIONS: Improvement in clinically relevant control end points occurred in both BUD/FM and BUD groups; both treatments were well tolerated in this Hispanic asthma population but were not significantly differentiated. |
| File Format | HTM / HTML |
| ISSN | 10811206 |
| Issue Number | 3 |
| Volume Number | 107 |
| e-ISSN | 15344436 |
| Journal | Annals of Allergy, Asthma & Immunology |
| Language | English |
| Publisher | Elsevier (on behalf of the American College of Allergy, Asthma and Immunology) |
| Publisher Date | 2011-09-01 |
| Publisher Place | United States |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Immunology Anti-asthmatic Agents Administration & Dosage Asthma Drug Therapy Bronchodilator Agents Budesonide Ethanolamines Glucocorticoids Metered Dose Inhalers Administration, Inhalation Adolescent Adult Therapeutic Use Drug Therapy, Combination Female Formoterol Fumarate Hispanic Americans Statistics & Numerical Data Humans Male Middle Aged Respiratory Function Tests Treatment Outcome Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pulmonary and Respiratory Medicine Immunology and Allergy Immunology |
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