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Tytuł pozycji:

INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD.

Tytuł :
INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD.
Autorzy :
Rossi A; Pulmonary Unit, University of Verona, Verona, Italy .
van der Molen T; University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
del Olmo R; Fundación CIDEA and Hospital Maria Ferrer, Buenos Aires, Argentina.
Papi A; University of Ferrara, Ferrara, Italy.
Wehbe L; Fundacion Enfisema, Buenos Aires, Argentina.
Quinn M; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Lu C; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Young D; Novartis Horsham Research Centre, Horsham, UK.
Cameron R; Novartis Horsham Research Centre, Horsham, UK.
Bucchioni E; Novartis Farma, Origgio, Italy.
Altman P; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
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Źródło :
The European respiratory journal [Eur Respir J] 2014 Dec; Vol. 44 (6), pp. 1548-56. Date of Electronic Publication: 2014 Oct 30.
Typ publikacji :
Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Język :
English
Imprint Name(s) :
Publication: Sheffield, United Kingdom : European Respiratory Society
Original Publication: Copenhagen : Published jointly by the Society and Munksgaard, 1988-
MeSH Terms :
Albuterol/*analogs & derivatives
Androstadienes/*therapeutic use
Bronchodilator Agents/*therapeutic use
Glucocorticoids/*therapeutic use
Indans/*therapeutic use
Pulmonary Disease, Chronic Obstructive/*drug therapy
Quinolones/*therapeutic use
Administration, Inhalation ; Aged ; Albuterol/therapeutic use ; Disease Progression ; Double-Blind Method ; Drug Combinations ; Drug Substitution ; Female ; Fluticasone-Salmeterol Drug Combination ; Forced Expiratory Volume ; Humans ; Male ; Middle Aged ; Severity of Illness Index ; Treatment Outcome ; Vital Capacity
Substance Nomenclature :
0 (Androstadienes)
0 (Bronchodilator Agents)
0 (Drug Combinations)
0 (Fluticasone-Salmeterol Drug Combination)
0 (Glucocorticoids)
0 (Indans)
0 (Quinolones)
8OR09251MQ (indacaterol)
QF8SVZ843E (Albuterol)
Entry Date(s) :
Date Created: 20141101 Date Completed: 20150720 Latest Revision: 20171116
Update Code :
20220302
DOI :
10.1183/09031936.00126814
PMID :
25359348
Czasopismo naukowe
The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease (COPD) exacerbations from salmeterol/fluticasone (SFC; inhaled corticosteroid (ICS) regimen) to indacaterol monotherapy (non-ICS regimen). This 26-week, double-blind, double-dummy, parallel-group, phase IV study, randomised 581 patients with moderate COPD to indacaterol 150 μg once daily or SFC 50/500 μg twice daily. Patients had been receiving SFC 50/500 μg for ≥3 months, with no COPD exacerbations for more than a year before the study (patients for whom ICS is not recommended). The primary objective was to demonstrate non-inferiority of indacaterol to SFC, measured by trough forced expiratory volume in 1 second (FEV₁) after 12 weeks (non-inferiority margin of 0.06 L). The primary objective was met, with a mean treatment difference of 9 mL (95% CI -45-26 mL). There were no significant differences between treatments in terms of breathlessness (transition dyspnoea index) or health status (Saint George's Respiratory Questionnaire) at weeks 12 or 26, or rescue medication use or COPD exacerbation rates over 26 weeks. Safety profiles of both treatments were as expected. This study demonstrated that patients with moderate COPD and no exacerbations in the previous year can be switched from SFC to indacaterol 150 μg with no efficacy loss.
(©ERS 2014.)
Comment in: Eur Respir J. 2014 Dec;44(6):1391-3. (PMID: 25435522)
Comment in: Eur Respir J. 2015 Apr;45(4):1187-8. (PMID: 25829433)
Comment in: Eur Respir J. 2015 Apr;45(4):1188-9. (PMID: 25829434)
Comment in: Expert Opin Pharmacother. 2015;16(10):1539-41. (PMID: 25936440)

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