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Randomized dose-ranging study of a budesonide metered-dose inhaler by using co-suspension delivery technology in asthma

Authors: S David, Miller; Jack, Nyberg; Shahid, Siddiqui; Paul, Dorinsky; Earl, St Rose; Colin, Reisner;

Randomized dose-ranging study of a budesonide metered-dose inhaler by using co-suspension delivery technology in asthma

Abstract

This is the first study of the inhaled corticosteroid, budesonide, delivered by metered-dose inhaler (BD MDI) using innovative co-suspension delivery technology in adults with asthma.To characterize the effects of BD delivered by MDI on lung function and safety.Randomized, double-blind, 4-week cross-over, placebo-controlled, phase IIb study of adults (18-65 years of age) with mild-to-moderate persistent asthma. The subjects received twice-daily BD MDI 320 μg, 160 μg, and placebo MDI, and either BD MDI 80 μg or 40 μg. The primary endpoint was change from baseline in morning trough forced expiratory volume in 1 second (FEV1) at the end of the treatment period (EOT). Secondary endpoints included change from baseline in morning and evening predose peak expiratory flow rate (PEFR), rescue medication use, and Asthma Control Questionnaire 5-question version (ACQ-5) score. Safety was also assessed.A total of 147 subjects were randomized. All doses of BD MDI improved morning trough FEV1 at EOT, and morning and evening predose PEFR in the last treatment week versus placebo (all p www.clinicaltrials.gov.

Keywords

Adult, Male, Adolescent, Dose-Response Relationship, Drug, Middle Aged, Asthma, Respiratory Function Tests, Young Adult, Treatment Outcome, Administration, Inhalation, Humans, Female, Anti-Asthmatic Agents, Metered Dose Inhalers, Budesonide, Aged

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Average
Average
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