An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler Compared With Usual Maintenance Therapy in Subjects With Asthma
1 other identifier
interventional
4,233
1 country
180
Brief Summary
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Nov 2012
Longer than P75 for phase_3 asthma
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2016
CompletedResults Posted
Study results publicly available
January 24, 2019
CompletedJanuary 24, 2019
July 1, 2018
4.1 years
October 4, 2012
December 6, 2017
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of \<20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented
Baseline (Day 0) and Week 24
Secondary Outcomes (22)
Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.
Baseline (Day 0) and Weeks 12, 40 and 52
Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
Weeks 12, 24, 40 and 52
Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
Baseline (Day 0) and Weeks 12, 24, 40 and 52
Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
Baseline (Day 0) and Weeks 12, 24, 40 and 52
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
Weeks 12, 24, 40 and 52
- +17 more secondary outcomes
Study Arms (2)
FF/VI
EXPERIMENTALfluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
ICS or ICS/LABA maintenance therapy
ACTIVE COMPARATORinhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)
Interventions
ICS alone or in combination with a long acting bronchodilator
Eligibility Criteria
You may qualify if:
- Subjects eligible for enrolment in the study must meet all of the following criteria:
- Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated.
- Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease.
- Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2.
- Other background asthma medication such as anti-leukotrienes are permitted
- All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject's recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines).
- Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf
- Gender and Age: Male or female subjects aged ≥18 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of:
- Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH \> 40MIU/ml and estradiol \<40pg/ml (\<147 pmol/L) is confirmatory.
- OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - Visit 2 to the end of the study).
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months.
- COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease.
- Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded.
- Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening)
- Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening)
- Subjects who are using LABA without an ICS as asthma maintenance therapy.
- Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (180)
GSK Investigational Site
Altrincham, Cheshire, WA14 2NW, United Kingdom
GSK Investigational Site
Altrincham, Cheshire, WA14 5ET, United Kingdom
GSK Investigational Site
Altrincham, Cheshire, WA14 5GR, United Kingdom
GSK Investigational Site
Altrincham, Cheshire, WA14 5NH, United Kingdom
GSK Investigational Site
Altrincham, Cheshire, WA14 5PF, United Kingdom
GSK Investigational Site
Bowdon, Cheshire, WA14 3BD, United Kingdom
GSK Investigational Site
Cheadle, Cheshire, SK8 6LQ, United Kingdom
GSK Investigational Site
Cheadle Hulme, Cheshire, SK8 5EG, United Kingdom
GSK Investigational Site
Edgeley, Cheshire, SK3 9LQ, United Kingdom
GSK Investigational Site
Gatley, Cheshire, SK84NG, United Kingdom
GSK Investigational Site
Heald Green, Cheshire, SK8 3QA, United Kingdom
GSK Investigational Site
Sale, Cheshire, M33 2RH, United Kingdom
GSK Investigational Site
Sale, Cheshire, M33 2UP, United Kingdom
GSK Investigational Site
Sale, Cheshire, M33 4BR, United Kingdom
GSK Investigational Site
Sale, Cheshire, M33 7SS, United Kingdom
GSK Investigational Site
Stockport, Cheshire, SK3 9NX, United Kingdom
GSK Investigational Site
Timperley, Cheshire, WA15 7DD, United Kingdom
GSK Investigational Site
Timperley, Cheshire, WA15 7UN, United Kingdom
GSK Investigational Site
Altrincham, Greater Manchester, WA14 2DW, United Kingdom
GSK Investigational Site
Altrincham, Greater Manchester, WA15 6PH, United Kingdom
GSK Investigational Site
Broadway, Davyhulme, Greater Manchester, M41 7WJ, United Kingdom
GSK Investigational Site
Irlam, Greater Manchester, M44 5LH, United Kingdom
GSK Investigational Site
Irlam, Manchester, Greater Manchester, M44 5LH, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M20 1EB, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M20 2DN, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M20 2RN, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M20 3BG, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M20 4SS, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M20 6WF, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M22 4DH, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M22 5DW, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M22 5RB, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M22 5RX, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M22 9UE, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M23 1JP, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M23 1JX, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M23 9AB, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M27 9LB, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M32 0DF, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M32 0PA, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M32 0RW, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 2TB, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 3HF, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 4WB, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 5JD, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 5PN, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 7SS, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M33 7XN, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 0NA, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 0SE, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 0TZ, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 5AA, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 7FN, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 7WJ, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, M41 8AA, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, WA15 6BP, United Kingdom
GSK Investigational Site
Manchester, Greater Manchester, WA15 7UN, United Kingdom
GSK Investigational Site
Newall Green, Greater Manchester, M23 2SY, United Kingdom
GSK Investigational Site
Northenden, Greater Manchester, M22 4DH, United Kingdom
GSK Investigational Site
Northern Moor, Greater Manchester, M23 0BX, United Kingdom
GSK Investigational Site
Pendlebury, Greater Manchester, M27 8HP, United Kingdom
GSK Investigational Site
Salford, Greater Manchester, M6 7HL, United Kingdom
GSK Investigational Site
Salford, Greater Manchester, M7 1RD, United Kingdom
GSK Investigational Site
Salford, Manchester, Greater Manchester, M6 6ES, United Kingdom
GSK Investigational Site
Salford, Manchester, Greater Manchester, M7 4TP, United Kingdom
GSK Investigational Site
Stretford, Greater Manchester, M32 9BD, United Kingdom
GSK Investigational Site
Timperley, Greater Manchester, WA15 6PH, United Kingdom
GSK Investigational Site
Withington, Greater Manchester, M20 1EY, United Kingdom
GSK Investigational Site
Wythenshawe, Greater Manchester, M22 0EP, United Kingdom
GSK Investigational Site
Wythenshawe, Greater Manchester, M22 5RN, United Kingdom
GSK Investigational Site
Wythenshawe, Greater Manchester, M22 5RX, United Kingdom
GSK Investigational Site
Cadishead, Manchester, M44 5DD, United Kingdom
GSK Investigational Site
Cheadle, SK8 5BB, United Kingdom
GSK Investigational Site
Eccles, M30 0TU, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 0EA, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 0EJ, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 0LS, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 0NU, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 0PF, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 0TU, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 7JW, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 7NA, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 8AR, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 8JA, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 8QD, United Kingdom
GSK Investigational Site
Eccles, Manchester, M30 9PS, United Kingdom
GSK Investigational Site
Ellenbrook, Manchester, M28 1PB, United Kingdom
GSK Investigational Site
Irlam, Manchester, M44 5LH, United Kingdom
GSK Investigational Site
Irlam, Manchester, M44 6AJ, United Kingdom
GSK Investigational Site
Irlam, Manchester, M44 6BL, United Kingdom
GSK Investigational Site
Irlam, Manchester, M44 6FE, United Kingdom
GSK Investigational Site
Irlam, Manchester, M44 6FN, United Kingdom
GSK Investigational Site
Irlam, Salford, M44 6ZS, United Kingdom
GSK Investigational Site
Little Hulton, Manchester, M28 0AY, United Kingdom
GSK Investigational Site
Little Hulton, Manchester, M28 0BA, United Kingdom
GSK Investigational Site
Little Hulton, Manchester, M38 9GR, United Kingdom
GSK Investigational Site
Little Hulton, Manchester, M38 9LQ, United Kingdom
GSK Investigational Site
Little Hulton, Manchester, M38 9RS, United Kingdom
GSK Investigational Site
Little Hulton, Manchester, M38 9WX, United Kingdom
GSK Investigational Site
Manchester, M16 0WL, United Kingdom
GSK Investigational Site
Manchester, M20 4SS, United Kingdom
GSK Investigational Site
Manchester, M22 4HD, United Kingdom
GSK Investigational Site
Manchester, M22 4QN, United Kingdom
GSK Investigational Site
Manchester, M22 9UH, United Kingdom
GSK Investigational Site
Manchester, M23 1JX, United Kingdom
GSK Investigational Site
Manchester, M23 9AB, United Kingdom
GSK Investigational Site
Manchester, M28 1PB, United Kingdom
GSK Investigational Site
Manchester, M32 0RN, United Kingdom
GSK Investigational Site
Manchester, M32 8AQ, United Kingdom
GSK Investigational Site
Manchester, M32 9PA, United Kingdom
GSK Investigational Site
Manchester, M33 3JS, United Kingdom
GSK Investigational Site
Manchester, M33 4DX, United Kingdom
GSK Investigational Site
Manchester, M33 7XZ, United Kingdom
GSK Investigational Site
Manchester, M41 5BG, United Kingdom
GSK Investigational Site
Manchester, M41 7AB, United Kingdom
GSK Investigational Site
Manchester, M41 7ZA, United Kingdom
GSK Investigational Site
Manchester, M41 8GY, United Kingdom
GSK Investigational Site
Manchester, M41 8TW, United Kingdom
GSK Investigational Site
Manchester, M41 9FD, United Kingdom
GSK Investigational Site
Manchester, M41 9NU, United Kingdom
GSK Investigational Site
Manchester, M41 9SB, United Kingdom
GSK Investigational Site
Manchester, M7 4PF, United Kingdom
GSK Investigational Site
Manchester, WA14 1RH, United Kingdom
GSK Investigational Site
Manchester, WA14 4LJ, United Kingdom
GSK Investigational Site
Manchester, WA15 9SZ, United Kingdom
GSK Investigational Site
Pendlebury, Manchester, M27 6EW, United Kingdom
GSK Investigational Site
Salford, M5 3PH, United Kingdom
GSK Investigational Site
Salford, M5 4BS, United Kingdom
GSK Investigational Site
Salford, M6 3PH, United Kingdom
GSK Investigational Site
Salford, M6 5FX, United Kingdom
GSK Investigational Site
Salford, M6 5JG, United Kingdom
GSK Investigational Site
Salford, M6 5PP, United Kingdom
GSK Investigational Site
Salford, M6 5QQ, United Kingdom
GSK Investigational Site
Salford, M6 6ES, United Kingdom
GSK Investigational Site
Salford, M7 3SE, United Kingdom
GSK Investigational Site
Salford, M7 4UF, United Kingdom
GSK Investigational Site
Salford, Manchester, M3 6AF, United Kingdom
GSK Investigational Site
Salford, Manchester, M3 6BY, United Kingdom
GSK Investigational Site
Salford, Manchester, M5 3TP, United Kingdom
GSK Investigational Site
Salford, Manchester, M5 4QU, United Kingdom
GSK Investigational Site
Salford, Manchester, M5 5HJ, United Kingdom
GSK Investigational Site
Salford, Manchester, M5 5JR, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5FX, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5JA, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5JS, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5PH, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5PW, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5WN, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 5WW, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 7GU, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 7HL, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 8HA, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 8LE, United Kingdom
GSK Investigational Site
Salford, Manchester, M6 8NR, United Kingdom
GSK Investigational Site
Salford, Manchester, M7 1QE, United Kingdom
GSK Investigational Site
Salford, Manchester, M7 1RD, United Kingdom
GSK Investigational Site
Salford, Manchester, M7 1UD, United Kingdom
GSK Investigational Site
Salford, Manchester, M7 3SE, United Kingdom
GSK Investigational Site
Salford, Manchester, M7 4AE, United Kingdom
GSK Investigational Site
Salford, Manchester, M7 4AS, United Kingdom
GSK Investigational Site
Stockport, SK2 7EY, United Kingdom
GSK Investigational Site
Stockport, SK3 9AD, United Kingdom
GSK Investigational Site
Stockport, SK8 3JD, United Kingdom
GSK Investigational Site
Stockport, SK8 3QA, United Kingdom
GSK Investigational Site
Stockport, SK8 5LL, United Kingdom
GSK Investigational Site
Swinton, M27 4BJ, United Kingdom
GSK Investigational Site
Swinton, M27 8HP, United Kingdom
GSK Investigational Site
Swinton, Manchester, M27 0EW, United Kingdom
GSK Investigational Site
Swinton, Manchester, M27 0NA, United Kingdom
GSK Investigational Site
Swinton, Manchester, M27 4AF, United Kingdom
GSK Investigational Site
Swinton, Manchester, M27 4BH, United Kingdom
GSK Investigational Site
Walkden, Manchester, M28 3AT, United Kingdom
GSK Investigational Site
Walkden, Manchester, M28 3BT, United Kingdom
GSK Investigational Site
Walkden, Manchester, M28 3DR, United Kingdom
GSK Investigational Site
Walkden, Manchester, M28 3ZD, United Kingdom
GSK Investigational Site
Walkden, Manchester, United Kingdom
GSK Investigational Site
Worsley, Manchester, M28 1FB, United Kingdom
GSK Investigational Site
Worsley, Manchester, M28 1LZ, United Kingdom
GSK Investigational Site
Worsley, Manchester, M28 3AT, United Kingdom
GSK Investigational Site
Wythenshawe, M22 0LA, United Kingdom
Related Publications (7)
Woodcock A, Janson C, Rees J, Frith L, Lofdahl M, Moore A, Hedberg M, Leather D. Effects of switching from a metered dose inhaler to a dry powder inhaler on climate emissions and asthma control: post-hoc analysis. Thorax. 2022 Dec;77(12):1187-1192. doi: 10.1136/thoraxjnl-2021-218088. Epub 2022 Feb 7.
PMID: 35131893DERIVEDKosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, Svedsater H. Psychometric properties of the Asthma Control Test in 2 randomized clinical trials. J Allergy Clin Immunol Pract. 2021 Jan;9(1):561-563.e1. doi: 10.1016/j.jaip.2020.07.040. Epub 2020 Aug 6. No abstract available.
PMID: 32771685DERIVEDSvedsater H, Jones R, Bosanquet N, Jacques L, Lay-Flurrie J, Leather DA, Vestbo J, Collier S, Woodcock A. Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study. Respir Med. 2018 Aug;141:198-206. doi: 10.1016/j.rmed.2018.06.003. Epub 2018 Jun 6.
PMID: 30053967DERIVEDJacques L, Bakerly ND, New JP, Svedsater H, Lay-Flurrie J, Leather DA. Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study. J Asthma. 2019 Jul;56(7):748-757. doi: 10.1080/02770903.2018.1490751. Epub 2018 Oct 16.
PMID: 29972089DERIVEDWoodcock 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; Salford Lung Study Investigators. Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial. Lancet. 2017 Nov 18;390(10109):2247-2255. doi: 10.1016/S0140-6736(17)32397-8. Epub 2017 Sep 10.
PMID: 28903864DERIVEDWoodcock A, Bakerly ND, New JP, Gibson JM, Wu W, Vestbo J, Leather D. The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma. BMC Pulm Med. 2015 Dec 10;15:160. doi: 10.1186/s12890-015-0150-8.
PMID: 26651333DERIVEDNew JP, Bakerly ND, Leather D, Woodcock A. Obtaining real-world evidence: the Salford Lung Study. Thorax. 2014 Dec;69(12):1152-4. doi: 10.1136/thoraxjnl-2014-205259. Epub 2014 Mar 6.
PMID: 24603195DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2012
First Posted
October 15, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 16, 2016
Last Updated
January 24, 2019
Results First Posted
January 24, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.