Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma.

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Research Abstract Details 

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Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Abstract Text:

Laurence J Brookman,Lisa J Knowles,Michaela Barbier,Brigitte Elharrar,Rainard Fuhr,Steve Pascoe,Laurence J Brookman,Lisa J Knowles,Michaela Barbier,Brigitte Elharrar,Rainard Fuhr,Steve Pascoe,Laurence J Brookman,Lisa J Knowles,Michaela Barbier,Brigitte Elharrar,Rainard Fuhr,Steve Pascoe,

OBJECTIVE: This study compared the bronchodilator efficacy and safety of indacaterol with placebo, salbutamol and salmeterol, in patients with persistent asthma, at single therapeutic and supratherapeutic doses. RESEARCH DESIGN AND METHODS: This was a randomised, open-label crossover study in adult subjects with asthma (forced expiratory volume in 1 second [FEV(1)] >/= 60% predicted). In part A, patients (n = 20) received single doses of indacaterol 200 mug, salbutamol 200 mug, salmeterol 50 mug and placebo. In part B, patients (n = 19) received single doses of indacaterol 1000 mug, salbutamol 1000 mug, salmeterol 250 mug and placebo. MAIN OUTCOMES MEASURES; RESULTS: For the primary endpoint, FEV(1) area under the effect curve during 0-24 h, indacaterol 200 mug was statistically superior to placebo and salbutamol. Indacaterol 200 mug FEV(1) was higher than placebo (5 min to 24 h), salbutamol 200 mug (4-24 h), and salmeterol 50 mug (5 and 15 min and 22 and 24 h). Few adverse events were reported; all were mild or moderate in severity. Initial changes were observed in glucose, potassium, heart rate and QTc interval, but all values remained within normal ranges. Values matched placebo levels after a shorter time for indacaterol 1000 mug than for salmeterol 250 mug. CONCLUSIONS: In this single-dose, open-label study, indacaterol 200 mug provided effective 24-h bronchodilation, with a longer duration than salmeterol 50 mug and a good overall safety profile. The sustained bronchodilation of indacaterol 1000 mug was not associated with sustained systemic adverse effects.

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Publishing Authors By Initials

LJ Brookman,LJ Knowles,M Barbier,B Elharrar,R Fuhr,S Pascoe,LJ Brookman,LJ Knowles,M Barbier,B Elharrar,R Fuhr,S Pascoe,LJ Brookman,LJ Knowles,M Barbier,B Elharrar,R Fuhr,S Pascoe,

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Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Current medical research and opinion

VOLUME: 23

Page Numbers: 3113-22

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ISSN: 1473-4877

DAY: 19

MONTH: Dec

YEAR: 2007

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Information

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LANGUAGE: eng

NlmUniqueID: 351014

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Grant and Affiliation Information for Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma.

AFFILIATION: Novartis Horsham Research Centre, Horsham, UK.

Country: England

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MEDLINETA: Curr Med Res Opin

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