Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial
(2012) In BMJ Open 2(1). p.000370-000370- Abstract
- Background: Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting beta(2) agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. Trial design: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Methods: Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 mu g OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 mg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0-4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points... (More)
- Background: Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting beta(2) agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. Trial design: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Methods: Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 mu g OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 mg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0-4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23-24 h postdose; day 29) and wm FEV1 (0-4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 mg or placebo in a 2: 1 ratio; all patients and investigators were blinded to active or placebo treatment. Results: 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0-4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI -3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0-4 h postdose wm FEV1 (mean difference 236 ml). Conclusion: FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD. Trial registration number: clinical trials. gov-NCT00731822. (Less)
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https://lup.lub.lu.se/record/3683630
- author
- Lotvall, J. ; Bakke, P. S. ; Bjermer, Leif LU ; Steinshamn, S. ; Scott-Wilson, C. ; Crim, C. ; Sanford, L. and Haumann, B.
- organization
- publishing date
- 2012
- type
- Contribution to journal
- publication status
- published
- subject
- in
- BMJ Open
- volume
- 2
- issue
- 1
- pages
- 000370 - 000370
- publisher
- BMJ Publishing Group
- external identifiers
-
- wos:000315037200020
- scopus:84859029764
- pmid:22267687
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2011-000370
- language
- English
- LU publication?
- yes
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- 4c96911d-e9e5-41c3-baa8-222c96ba5808 (old id 3683630)
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- 2016-04-01 13:07:04
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- 2022-02-19 03:01:47
@article{4c96911d-e9e5-41c3-baa8-222c96ba5808,
abstract = {{Background: Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting beta(2) agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. Trial design: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Methods: Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 mu g OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 mg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0-4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23-24 h postdose; day 29) and wm FEV1 (0-4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 mg or placebo in a 2: 1 ratio; all patients and investigators were blinded to active or placebo treatment. Results: 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0-4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI -3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0-4 h postdose wm FEV1 (mean difference 236 ml). Conclusion: FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD. Trial registration number: clinical trials. gov-NCT00731822.}},
author = {{Lotvall, J. and Bakke, P. S. and Bjermer, Leif and Steinshamn, S. and Scott-Wilson, C. and Crim, C. and Sanford, L. and Haumann, B.}},
issn = {{2044-6055}},
language = {{eng}},
number = {{1}},
pages = {{000370--000370}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial}},
url = {{https://lup.lub.lu.se/search/files/3166641/4053727.pdf}},
doi = {{10.1136/bmjopen-2011-000370}},
volume = {{2}},
year = {{2012}},
}