| Title: |
Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial |
| Authors: |
Woodcock, A; Vestbo, J; Bakerly, ND; New, J; Gibson, JM; McCorkindale, S; Jones, R; Collier, S; Lay-Flurrie, J; Frith, L; Jacques, L; Fletcher, JL; Harvey, C; Svedsater, H; Leather, D; Adams-Strump, D; Addlestone, LS; Afshar, A; Amin, J; Archer, R; Austin, M; Bakhat, A; Behardien, J; Borg-Costanzi, JM; Breen, G; Browne, N; Brunt, C; Buch, KH; Budden, P; Chandy, J; Chaudhry, A; Cheema, L; Chennupati, N; Coulson, S; Cribbin, L; Dillon, D; El-Kafrawy, A; Elliott, E; Farooq, B; Finegan, NA; Fink, P; Fletcher, A; Frier, S; Gibbons, C; Gill, L; Herron, D; Hope, B; Howard, RE; Hughes, C; Iles, S; Jackson, P; Jarvis, M; Joshi, V; Kanumilli, N; Khan, RA; Khan, M; Kwok, S; Lord, N; Mafunga, C; Malcomson, CI; McCarthy, DK; Milligan, HS; Patel, P; Patel, SJ; Raj, VB; Richardson, KA; Salim, R; Seaton, RB; Shah, D; Sharma, M; Singh, H; Smith, N; Smyrniou, NN; Stamp, M; Stratford-Smith, P; Sultan, M; Sumra, RS; Tankel, J; Umeadi, UIN; Westwood, C; White, J; Wilkinson, HC; Wilson, RG; Wright, SA; Wright, AT |
| Publisher Information: |
Elsevier; England |
| Publication Year: |
2017 |
| Collection: |
PEARL (Plymouth Electronic Archiv & ResearchLibrary, Plymouth University) |
| Subject Terms: |
Administration; Inhalation; Adult; Ambulatory Care; Asthma; Benzyl Alcohols; Bronchodilator Agents; Chlorobenzenes; Confidence Intervals; Dose-Response Relationship; Drug; Drug Administration Schedule; Drug Therapy; Combination; Female; Fluticasone; Follow-Up Studies; General Practice; Humans; Male; Middle Aged; Prospective Studies; Respiratory Function Tests; Severity of Illness Index; Treatment Outcome; United Kingdom; Young Adult |
| Description: |
BACKGROUND: Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice. METHODS: We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01706198. FINDINGS: Between Nov 12, 2012, and Dec 16, 2016, 4725 patients were enrolled and 4233 randomly assigned to initiate treatment with fluticasone furoate and vilanterol (n=2114) or usual care (n=2119). 1207 patients (605 assigned to usual care, 602 to fluticasone furoate and vilanterol) had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. At week 24, the odds of being a responder were higher for patients who initiated treatment with fluticasone furoate and vilanterol than for those on usual care (977 [71%] of 1373 in the fluticasone furoate and vilanterol group vs 784 [56%] of 1399 in the usual care group; odds ratio [OR] 2·00 [95% CI 1·70-2·34], p |
| Document Type: |
article in journal/newspaper |
| File Description: |
2247-2255; Print-Electronic; application/pdf |
| Language: |
English |
| ISSN: |
0140-6736; 1474-547X |
| Relation: |
E-ISSN:1474-547X; http://hdl.handle.net/10026.1/10466 |
| DOI: |
10.1016/S0140-6736(17)32397-8 |
| Availability: |
http://hdl.handle.net/10026.1/10466; https://doi.org/10.1016/S0140-6736(17)32397-8 |
| Accession Number: |
edsbas.13A20210 |
| Database: |
BASE |