Chest
Original ResearchBudesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial
Section snippets
Materials and Methods
This double-blind, randomized, parallel-group, active-controlled study (study No. 0667) was conducted at 77 centers in Argentina, Brazil, China, Denmark, Indonesia, Norway, the Philippines, Spain, and Sweden. The study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulations (each study center received ethical approval of the protocol prior to study commencement). Adult patients and parents/guardians of underage children were
Results
From a total of 919 patients enrolled in the study, 697 patients (270 males) aged 11 to 79 years (mean age, 38 years) were randomized to treatment with either budesonide/formoterol in a single inhaler for both maintenance and relief (n = 355) or double-dose budesonide plus as-needed terbutaline (n = 342). A total of 58 patients discontinued the study: 27 patients in the budesonide/formoterol group (19 because eligibility criteria were not fulfilled, 3 because of adverse events [cramps,
Discussion
This study is the first of its kind in the management of mild-to-moderate asthma demonstrating that asthma control can be improved using budesonide and formoterol in a single inhaler for both maintenance and as-needed relief, without the need for a separate inhaler containing reliever medication. Budesonide/formoterol for both maintenance and relief was more effective than traditional asthma therapy using a higher dose of budesonide alone, as demonstrated by improved lung function, reduction in
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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).
Prof. Rabe has been a consultant, participated in Advisory Board Meetings, and received lecture fees from AstraZeneca, Boehringer, Pfizer, Novartis, AltanaPharma, Merck, Sharp and Dohme, and GlaxoSmithKline. Prof. Pizzichini has received reimbursement from AstraZeneca to participate in the 2004 American Academy of Allergy, Asthma & Immunology and European Respiratory Society meetings, during which results/analyses from the submitted study were presented as posters. Dr. Ställberg has received consultancy fees from AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline. Dr. Ställberg has also received fees for organizing educational meetings and fees for speaking at meetings from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Sharp and Dohme, Pharmacia, and Schering-Plough. Dr. Romero has received consultancy fees from AstraZeneca. Dr. Lier has received small fees from AstraZeneca during the last 5 years for speaking at local meetings for general practitioners. Dr. Jorup is a full-time employee of AstraZeneca and holds shares in the company.
This study was sponsored by AstraZeneca, Lund, Sweden.