Budesonide/formoterol pressurized metered-dose inhaler versus budesonide: a randomized controlled trial in black patients with asthma.

Abstract

OBJECTIVE:

Concerns exist that responses to long-acting β(2)-adrenergic agonists in black patients may differ from the general population. The efficacy and safety of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) versus budesonide dry powder inhaler (BUD DPI) were evaluated in adolescent and adult black asthma patients.

METHODS:

This 12-week, randomized, double-blind, multicenter, phase IV US study was conducted in 311 self-reported black patients aged ≥12 years with moderate to severe persistent asthma, previously receiving medium- to high-dose inhaled corticosteroid. After 2 weeks on BUD 90 μg × 2 inhalations twice daily (bid), symptomatic patients were randomized to BUD/FM 160/4.5 μg × 2 inhalations bid or BUD 180 μg × 2 inhalations bid.

RESULTS:

Improvement in predose forced expiratory volume in 1 second from baseline to the treatment mean (primary variable) was greater with BUD/FM versus BUD (0.16 vs. 0.07 L; p = .008); this effect was also observed at weeks 2, 6, and end of treatment (p ≤ .032). Greater improvements (p < .001) in peak expiratory flow with BUD/FM versus BUD were seen at first measurement and maintained during 12 weeks (morning: 25.34 vs. 7.53 L/minute, respectively; evening: 21.61 vs. 7.67 L/minute, respectively); greater improvements in daily asthma symptom score and rescue medication use were also observed (p ≤ .039). Both treatments were well tolerated, with similar safety profiles.

CONCLUSIONS:

In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.

• Authors: Sheldon L Spector, Ubaldo J Martin, Tom Uryniak, Christopher D O'Brien
• Journal: The Journal of asthma : official journal of the Association for the Care of Asthma (J Asthma) Vol. 49 Issue 1 Pg. 70-7 (Feb 2012) ISSN: 1532-4303 [Electronic] England
• PMID: 22133208 (Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Ethanolamines
• Budesonide
• Formoterol Fumarate

Topics

• Administration, Inhalation
• Adolescent
• Adult
• Black or African American (statistics & numerical data)
• Aged
• Asthma (diagnosis, drug therapy, ethnology)
• Budesonide (administration & dosage)
• Child
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Drug Therapy, Combination
• Ethanolamines (administration & dosage)
• Female
• Follow-Up Studies
• Formoterol Fumarate
• Humans
• Male
• Metered Dose Inhalers
• Middle Aged
• Multivariate Analysis
• Reference Values
• Respiratory Function Tests
• Severity of Illness Index
• Treatment Outcome
• Young Adult