NDLI: Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study.

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Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study.

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Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Saito, Takefumi Hasunuma, Tomoko
Spatial Coverage	Japan
Description	Country affiliation: Japan Author Affiliation: Saito T ( Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital, 825 Terunuma Tokaimura, Naka-gun, Ibaraki, Japan. takefumisaito@yahoo.co.jp)
Abstract	BACKGROUND: The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. OBJECTIVE: This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of the inhaled corticosteroid budesonide and the long-acting ß(2)-adrenoceptor agonist formoterol with that of the ß(2)-agonist terbutaline for acute symptom relief in Japanese adults with persistent asthma who were already receiving a combination of budesonide/formoterol maintenance therapy. METHODS: This was a randomized, double-blind, crossover, active comparator-controlled, phase III study. Patients aged 16-65 years with persistent asthma received either budesonide/formoterol 160 µg/4.5 µg ten inhalations daily for 3 days via Turbuhaler® or terbutaline 0.4 mg ten inhalations daily for 3 days via Turbuhaler®, in addition to budesonide/formoterol 160 µg/4.5 µg one inhalation twice daily as maintenance treatment. After a 7- to 14-day washout period, patients crossed over to receive the other medication for a further 3 days. Adverse events (AEs), clinical laboratory variables, 12-lead electrocardiogram (ECG) and vital signs were assessed throughout. RESULTS: Twenty-five patients (mean age 44.3 years, 40% female) were randomized and received at least one dose of study medication. Overall, 14 AEs were reported in 12 out of 25 patients (48%) during high-dose budesonide/formoterol therapy and 24 AEs were reported in 14 out of 23 patients (61%) during terbutaline therapy. The majority of AEs were mild in intensity and no serious AEs were reported. The most common AEs were tremor (12%) during budesonide/formoterol therapy and tremor (17%), palpitations (13%), tachycardia (13%) and decreased serum potassium (13%) during terbutaline therapy. There were no clinically significant differences from baseline or between groups in laboratory values, vital signs or ECG recordings. conclusion: Budesonide/formoterol 160 µg/4.5 µg ten inhalations daily for 3 days in addition to ongoing budesonide/formoterol 160 µg/4.5 µg one inhalation twice daily maintenance therapy was well tolerated in Japanese adults with persistent asthma. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00837967; AstraZeneca study code: D589LC00003.
File Format	HTM / HTML
ISSN	11732563
Issue Number	1
Volume Number	32
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2012-01-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Asthma Drug Therapy Bronchodilator Agents Therapeutic Use Budesonide Ethanolamines Adolescent Adult Aged Administration & Dosage Cross-over Studies Double-blind Method Drug Combinations Formoterol Fumarate Humans Japan Middle Aged Young Adult Clinical Trial, Phase Iii Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study.