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http://hdl.handle.net/1942/11840
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DC Field | Value | Language |
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dc.contributor.author | LaForce, Craig | - |
dc.contributor.author | AUMANN, Joseph | - |
dc.contributor.author | de Teresa Parreno, Luis | - |
dc.contributor.author | Iqbal, Amir | - |
dc.contributor.author | Young, David | - |
dc.contributor.author | Owen, Roger | - |
dc.contributor.author | Higgins, Mark | - |
dc.contributor.author | Kramer, Benjamin | - |
dc.date.accessioned | 2011-04-05T11:18:45Z | - |
dc.date.available | NO_RESTRICTION | - |
dc.date.available | 2011-04-05T11:18:45Z | - |
dc.date.issued | 2011 | - |
dc.identifier.citation | PULMONARY PHARMACOLOGY & THERAPEUTICS, 24(1). p. 162-168 | - |
dc.identifier.issn | 1094-5539 | - |
dc.identifier.uri | http://hdl.handle.net/1942/11840 | - |
dc.description.abstract | Purpose: Indacaterol is a novel, once daily, inhaled ultra-long-acting beta(2)-agonist for the treatment of chronic obstructive pulmonary disease (COPD). Here we compared the 24-h spirometry profile of once daily indacaterol 300 mu g with that of placebo and twice daily salmeterol 50 mu g in patients with COPD. Methods: This randomized, multicenter, placebo-controlled, crossover study comprised three 14-day treatment periods (with 14-day washouts). Patients (male/female >= 40 years) with moderate-to-severe COPD were randomized to receive double-blind indacaterol 300 mu g or placebo once daily, or open-label salmeterol 50 mu g twice daily. The primary outcome measure was 24-h post-dose (trough) FEV1 (mean of FEV1 at 23 h 10 min and 23 h 45 min post-indacaterol dose) after 14 days. FEV1 was assessed at multiple time points on Days 1 and 14 of each treatment period. Safety and tolerability were also monitored. Results: Of 68 randomized patients, 61 completed. Trough FEV1 (primary endpoint) on Day 14 for indacaterol was 200 mL higher than placebo (p < 0.001), exceeding the prespecified minimum clinically important difference (120 mL), and was 90 mL higher than for salmeterol (p = 0.011). After Day 1, trough FEV1 for indacaterol was 150 mL higher than placebo (p < 0.001). Indacaterol provided superior bronchodilation compared with placebo (p < 0.001) across the full 24-h assessment period on Days 1 and 14. In addition, on both days, indacaterol provided superior FEV1 compared with salmeterol (p < 0.05) at many post-baseline time points, including 5 min post-dose. All treatments were well tolerated. Conclusions: Once daily indacaterol 300 mu g produced effective sustained 24-h bronchodilation from the first dose, an efficacy profile superior to placebo and twice daily salmeterol. Given its effective bronchodilation with once daily dosing, indacaterol is likely to be a useful treatment option for patients with moderate-to-severe COPD. (C) 2010 Elsevier Ltd. All rights reserved. | - |
dc.description.sponsorship | This study was funded by Novartis Pharma AG, Basel, Switzerland. The sponsor (represented by AI, DY, RO, MH and BK) was responsible for the design and analysis of the study, and for the writing of the study report. CLF. JA and LdTP were involved in the collection of data. | - |
dc.language.iso | en | - |
dc.publisher | ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD | - |
dc.subject.other | Indacaterol; Salmeterol; COPD; Bronchodilation; FEV1; Inspiratory capacity | - |
dc.title | Sustained 24-hour efficacy of once daily indacaterol (300 mu g) in patients with chronic obstructive pulmonary disease: A randomized, crossover study | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 168 | - |
dc.identifier.issue | 1 | - |
dc.identifier.spage | 162 | - |
dc.identifier.volume | 24 | - |
local.format.pages | 7 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | [Kramer, Benjamin] Novartis Pharmaceut, E Hanover, NJ 07936 USA. [LaForce, Craig] N Carolina Clin Res, Raleigh, NC USA. [Aumann, Joseph] Associatie Longziekten Hasselt, Kunstlaan, Belgium. [de Teresa Parreno, Luis] Clin Mediterranea Neurociencias, Alicante, Spain. [Iqbal, Amir; Young, David; Owen, Roger; Higgins, Mark] Novartis Horsham Res Ctr, Horsham RH12 5AB, W Sussex, England. benjamin.kramer@novartis.com | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.bibliographicCitation.oldjcat | A1 | - |
dc.identifier.doi | 10.1016/j.pupt.2010.06.005 | - |
dc.identifier.isi | 000288300600022 | - |
item.fulltext | With Fulltext | - |
item.accessRights | Restricted Access | - |
item.contributor | LaForce, Craig | - |
item.contributor | AUMANN, Joseph | - |
item.contributor | de Teresa Parreno, Luis | - |
item.contributor | Iqbal, Amir | - |
item.contributor | Young, David | - |
item.contributor | Owen, Roger | - |
item.contributor | Higgins, Mark | - |
item.contributor | Kramer, Benjamin | - |
item.fullcitation | LaForce, Craig; AUMANN, Joseph; de Teresa Parreno, Luis; Iqbal, Amir; Young, David; Owen, Roger; Higgins, Mark & Kramer, Benjamin (2011) Sustained 24-hour efficacy of once daily indacaterol (300 mu g) in patients with chronic obstructive pulmonary disease: A randomized, crossover study. In: PULMONARY PHARMACOLOGY & THERAPEUTICS, 24(1). p. 162-168. | - |
item.validation | ecoom 2012 | - |
crisitem.journal.issn | 1094-5539 | - |
Appears in Collections: | Research publications |
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aumann.pdf Restricted Access | Published version | 278.84 kB | Adobe PDF | View/Open Request a copy |
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