Matches in SemOpenAlex for { <https://semopenalex.org/work/W1919049020> ?p ?o ?g. }
Showing items 1 to 80 of
80
with 100 items per page.
- W1919049020 startingPage "2093" @default.
- W1919049020 abstract "QMF is an investigational once-daily (QD), fixed-dose combination of indacaterol (IND) and mometasone furoate (MF). This study assessed the long-term safety of QMF in patients (pts) with persistent asthma. In this randomized, double-blind, multi-centre, Phase II study, pts (12–70 y) received QMF (IND maleate 500µg/MF 400µg) or MF (400µg), both administered QD via the Twisthaler®* for 6–21 months. Systemic exposure data show that this QMF dose is comparable to 150µg IND/160µg MF in the Concept1 (Breezhaler®) inhalation device, the delivery device that will be used in future studies. The primary endpoint was time to first serious exacerbation (resulting in hospitalisation, intubation or death). A key secondary endpoint was the cumulative incidence of serious exacerbations. AEs and SAEs were recorded. 8 of 1519 randomised pts (QMF, 756; MF, 763) were hospitalised for a serious exacerbation (QMF, 2; MF, 6); none required intubation or resulted in death. QMF reduced the risk of a serious exacerbation vs MF by 69% (hazard ratio=0.31; 90% CI 0.08, 1.19; p=0.076). The difference in cumulative incidence was -0.52 percentage points (90% CI -1.14, 0.09) in favor of QMF, meeting the pre-specified, non-inferiority margin of 1 percentage point. Similar proportions of pts experienced AEs and SAEs in both groups (QMF, 74.0% and 4.0%; MF, 73.4% and 5.8%). Most frequent AEs with QMF and MF were cough and asthma, respectively. There was one death (MF group), which was not treatment or asthma related. Mean plasma MF concentrations were similar in both groups. QMF QD was not associated with additional safety concerns vs MF monotherapy in pts with persistent asthma. * Twisthaler® is a registered trademark of Schering-Plough LTD." @default.
- W1919049020 created "2016-06-24" @default.
- W1919049020 creator A5002947939 @default.
- W1919049020 creator A5013167015 @default.
- W1919049020 creator A5030571912 @default.
- W1919049020 creator A5056591946 @default.
- W1919049020 creator A5067040413 @default.
- W1919049020 creator A5071987600 @default.
- W1919049020 creator A5080119643 @default.
- W1919049020 date "2012-09-01" @default.
- W1919049020 modified "2023-10-01" @default.
- W1919049020 title "Safety of once-daily QMF149 in patients with persistent asthma" @default.
- W1919049020 hasPublicationYear "2012" @default.
- W1919049020 type Work @default.
- W1919049020 sameAs 1919049020 @default.
- W1919049020 citedByCount "0" @default.
- W1919049020 crossrefType "journal-article" @default.
- W1919049020 hasAuthorship W1919049020A5002947939 @default.
- W1919049020 hasAuthorship W1919049020A5013167015 @default.
- W1919049020 hasAuthorship W1919049020A5030571912 @default.
- W1919049020 hasAuthorship W1919049020A5056591946 @default.
- W1919049020 hasAuthorship W1919049020A5067040413 @default.
- W1919049020 hasAuthorship W1919049020A5071987600 @default.
- W1919049020 hasAuthorship W1919049020A5080119643 @default.
- W1919049020 hasConcept C120665830 @default.
- W1919049020 hasConcept C121332964 @default.
- W1919049020 hasConcept C126322002 @default.
- W1919049020 hasConcept C168563851 @default.
- W1919049020 hasConcept C197934379 @default.
- W1919049020 hasConcept C203092338 @default.
- W1919049020 hasConcept C207103383 @default.
- W1919049020 hasConcept C2776042228 @default.
- W1919049020 hasConcept C2776954882 @default.
- W1919049020 hasConcept C2777014857 @default.
- W1919049020 hasConcept C2778884479 @default.
- W1919049020 hasConcept C2781018748 @default.
- W1919049020 hasConcept C2909082789 @default.
- W1919049020 hasConcept C2911091166 @default.
- W1919049020 hasConcept C42219234 @default.
- W1919049020 hasConcept C44249647 @default.
- W1919049020 hasConcept C61511704 @default.
- W1919049020 hasConcept C71924100 @default.
- W1919049020 hasConcept C88879693 @default.
- W1919049020 hasConceptScore W1919049020C120665830 @default.
- W1919049020 hasConceptScore W1919049020C121332964 @default.
- W1919049020 hasConceptScore W1919049020C126322002 @default.
- W1919049020 hasConceptScore W1919049020C168563851 @default.
- W1919049020 hasConceptScore W1919049020C197934379 @default.
- W1919049020 hasConceptScore W1919049020C203092338 @default.
- W1919049020 hasConceptScore W1919049020C207103383 @default.
- W1919049020 hasConceptScore W1919049020C2776042228 @default.
- W1919049020 hasConceptScore W1919049020C2776954882 @default.
- W1919049020 hasConceptScore W1919049020C2777014857 @default.
- W1919049020 hasConceptScore W1919049020C2778884479 @default.
- W1919049020 hasConceptScore W1919049020C2781018748 @default.
- W1919049020 hasConceptScore W1919049020C2909082789 @default.
- W1919049020 hasConceptScore W1919049020C2911091166 @default.
- W1919049020 hasConceptScore W1919049020C42219234 @default.
- W1919049020 hasConceptScore W1919049020C44249647 @default.
- W1919049020 hasConceptScore W1919049020C61511704 @default.
- W1919049020 hasConceptScore W1919049020C71924100 @default.
- W1919049020 hasConceptScore W1919049020C88879693 @default.
- W1919049020 hasOpenAccess W1919049020 @default.
- W1919049020 hasRelatedWork W1792748867 @default.
- W1919049020 hasRelatedWork W2019643126 @default.
- W1919049020 hasRelatedWork W2087556596 @default.
- W1919049020 hasRelatedWork W2513258422 @default.
- W1919049020 hasRelatedWork W2549906303 @default.
- W1919049020 hasRelatedWork W2550936617 @default.
- W1919049020 hasRelatedWork W2575157483 @default.
- W1919049020 hasRelatedWork W2918169471 @default.
- W1919049020 hasRelatedWork W2959876323 @default.
- W1919049020 hasRelatedWork W3096509866 @default.
- W1919049020 hasRelatedWork W3159458516 @default.
- W1919049020 hasVolume "40" @default.
- W1919049020 isParatext "false" @default.
- W1919049020 isRetracted "false" @default.
- W1919049020 magId "1919049020" @default.
- W1919049020 workType "article" @default.