Effects of once-daily formoterol and budesonide given alone or in combination on surrogate inflammatory markers in asthmatic adults

Aziz, Imran, Wilson, Andrew M. and Lipworth, Brian J. (2008) Effects of once-daily formoterol and budesonide given alone or in combination on surrogate inflammatory markers in asthmatic adults. Chest, 118 (4). pp. 1049-1058. ISSN 1931-3543

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Abstract

Objectives: We wished to evaluate the effects of once-daily combination therapy on surrogate inflammatory markers. Methods: Fifteen patients with atopic persistent asthmawere evaluated (mean age, 32.4 years; FEV1, 75.2%predicted) in a randomized, double-blind, double-dummy, placebo-controlled crossover study with a 1-week placebo washoutperiod, comparing the following once-daily nighttime treatments: (1)formoterol (FM), 12 μg, for 2 weeks and FM, 24 μg, for 2 weeks; or(2) budesonide (BUD), 400 μg, for 2 weeks and BUD, 800 μg, for2 weeks; or (3) FM, 12 μg, plus BUD, 400 μg, for 2 weeks and FM, 24μg, plus BUD, 800 μg, for 2 weeks. Adenosine monophosphate (AMP)bronchial challenge, exhaled nitric oxide (NO), and serum eosinophiliccationic protein (ECP) were evaluated at 12 h postdosing afteradministration of each placebo and after 2 and 4 weeks of eachtreatment. Results: The results of AMP challenge(provocative concentration causing a 20% fall in FEV1) at4 weeks showed significant (p < 0.05) improvements after patientshad received all active treatments compared to placebo (20 mg/mL), withFM plus BUD, 261 mg/mL, being superior (p < 0.05) to FM alone, 82mg/mL, but not to BUD, 201 mg/mL. NO and ECP showed significant(p < 0.05) reductions compared to placebo with FM plus BUD or BUDalone but not with FM alone. Combination therapy was associatedwith optimal patient preference (rank order, FM plus BUD > FM>BUD; p < 0.0005), highest domiciliary peak expiratoryflow, and lowest rescue inhaler usage. All three treatmentsproduced equivalent improvements in spirometry. Conclusions: Patients preferred once-daily combinationtherapy, but this had no greater effect on inflammatory markers thantherapy with BUD alone. FM alone had no anti-inflammatory activity butexhibited bronchoprotection. This emphasizes the importance of firstoptimizing anti-inflammatory control with inhaled corticosteroidsbefore considering adding a regular long-actingβ2-agonist.

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Respiratory and Airways Group
Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health
Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit
Faculty of Medicine and Health Sciences > Research Centres > Population Health
Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
Depositing User: EPrints Services
Date Deposited: 25 Nov 2010 11:12
Last Modified: 13 Nov 2023 16:51
URI: https://ueaeprints.uea.ac.uk/id/eprint/14925
DOI: 10.1378/chest.118.4.1049

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