A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
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 (NDPI) Compared With the Existing COPD Maintenance Therapy Alone in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
2,802
1 country
178
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)) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed with COPD. 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
Started Mar 2012
Typical duration for phase_3
178 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedStudy Start
First participant enrolled
March 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2015
CompletedResults Posted
Study results publicly available
March 7, 2017
CompletedMay 31, 2017
May 1, 2017
3.7 years
March 1, 2012
September 5, 2016
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Annual Rate of Moderate or Severe COPD Exacerbations
Mean annual rate of moderate or severe COPD exacerbations during treatment were assessed. Moderate exacerbation: participant received exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with/without National Health Service \[NHS\] contact) not requiring hospitalisation. Severe exacerbation: an exacerbation-related hospitalisation. Analysis method was Generalised Linear Model (GLM) assuming the negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable, adjusted for randomized treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in previous year and smoking status at baseline. Intent to treat (ITT) population: all randomised participants who received a prescription of study medication. Primary Efficacy Analysis Population: all ITT participants who had at least one moderate/severe exacerbation in the year prior to randomization
Up to 54 weeks
Secondary Outcomes (16)
Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study
Up to 58 weeks
Mean Number of Serious Adverse Events of Pneumonia During the Study
Up to 58 weeks
Time to the First Serious Adverse Event of Pneumonia Occuring in a Year
Up to 52 weeks
Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean
Up to 54 weeks
Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean
Up to 54 weeks
- +11 more secondary outcomes
Study Arms (2)
FF/VI
EXPERIMENTALonce daily via a Novel Dry Powder Inhaler
Existing Maintenance Therapy
OTHERExisting Maintenance Therapy: * Long acting bronchodilator therapy alone * ICS alone or in combination with a long acting bronchodilator * Triple maintenance therapy
Interventions
Existing Maintenance Therapy: * Long acting bronchodilator therapy alone * ICS alone or in combination with a long acting bronchodilator * Triple maintenance therapy
Eligibility Criteria
You may qualify if:
- Subjects eligible for enrolment in the study must meet all of the following criteria:
- Type of subject: Subjects with documented GP diagnosis of COPD, and currently receiving maintenance therapy
- Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated. Subjects must be able to complete the electronic subject questionnaires or allow a proxy to do so on their behalf.
- Gender and Age: Male or female subjects aged ≥40 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 (\<140 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).
- Subjects with Exacerbation History
- Current COPD Maintenance Therapy
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Subjects with any life threatening condition (e.g. low probability (in the opinion of the GP/Investigator) of 12 month survival due to severity of COPD or co-morbid condition) at the point of entry into the study.
- 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.
- Subjects with unstable COPD, defined as the occurrence of the following in the 2 weeks prior to Visit 2:
- \- Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
- Chronic user of oral corticosteroids: Subjects who, in the opinion of the GP/Investigator, are considered to be a chronic user of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening)
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-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 treatment within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two).
- 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 (178)
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
Pendlebury, Manchester, Greater Manchester, M27 8HP, United Kingdom
GSK Investigational Site
Salford, Greater Manchester, M6 5PW, United Kingdom
GSK Investigational Site
Salford, Greater Manchester, M6 6ES, 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, 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 6DP, 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 9GH, 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, M20 4SS, United Kingdom
GSK Investigational Site
Manchester, M22 4HD, United Kingdom
GSK Investigational Site
Manchester, M22 4QN, United Kingdom
GSK Investigational Site
Manchester, M23 1JX, United Kingdom
GSK Investigational Site
Manchester, M28 1PB, 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 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
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 4LZ, United Kingdom
GSK Investigational Site
Salford, M7 4NX, 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 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 3EZ, 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 (8)
Vestbo J, Waterer G, Leather D, Crim C, Diar Bakerly N, Frith L, Jacques L, Harvey C, Satia I, Woodcock A; Salford Lung Study Investigators. Mortality after admission with pneumonia is higher than after admission with an exacerbation of COPD. Eur Respir J. 2022 May 19;59(5):2102899. doi: 10.1183/13993003.02899-2021. Print 2022 May.
PMID: 35273031DERIVEDBakerly ND, Browning D, Boucot I, Crawford J, McCorkindale S, Stein N, New JP. The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211001013. doi: 10.1177/17534666211001013.
PMID: 33781142DERIVEDSperrin M, Webb DJ, Patel P, Davis KJ, Collier S, Pate A, Leather DA, Pimenta JM. Chronic obstructive pulmonary disease exacerbation episodes derived from electronic health record data validated using clinical trial data. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1369-1376. doi: 10.1002/pds.4883. Epub 2019 Aug 5.
PMID: 31385428DERIVEDBakerly ND, Woodcock A, Collier S, Leather DA, New JP, Crawford J, Harvey C, Vestbo J, Boucot I. Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups. Respir Med. 2019 Feb;147:58-65. doi: 10.1016/j.rmed.2018.12.016. Epub 2019 Jan 10.
PMID: 30704700DERIVEDWoodcock A, Boucot I, Leather DA, Crawford J, Collier S, Bakerly ND, Hilton E, Vestbo J. Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability. Eur Respir J. 2018 Feb 21;51(2):1701531. doi: 10.1183/13993003.01531-2017. Print 2018 Feb.
PMID: 29467200DERIVEDVestbo J, Leather D, Diar Bakerly N, New J, Gibson JM, McCorkindale S, Collier S, Crawford J, Frith L, Harvey C, Svedsater H, Woodcock A; Salford Lung Study Investigators. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. N Engl J Med. 2016 Sep 29;375(13):1253-60. doi: 10.1056/NEJMoa1608033. Epub 2016 Sep 4.
PMID: 27593504DERIVEDBakerly ND, Woodcock A, New JP, Gibson JM, Wu W, Leather D, Vestbo J. The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease. Respir Res. 2015 Sep 4;16(1):101. doi: 10.1186/s12931-015-0267-6.
PMID: 26337978DERIVEDNew 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
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
March 1, 2012
First Posted
March 13, 2012
Study Start
March 13, 2012
Primary Completion
November 24, 2015
Study Completion
November 24, 2015
Last Updated
May 31, 2017
Results First Posted
March 7, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.