Clinical trial NCT01551758: A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Exacerbation
Adult
COPD
Respiratory
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 2802
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a Phase III multi-centre, randomised open label study performed in subjects followed in primary care who have a diagnosis of and receive regular treatment for COPD in a localised geographical region of the UK

Eligibility criteria: Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Type of subject: Subjects with documented GP diagnosis of COPD, and currently receiving maintenance therapy
2. 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.
3. 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).
4. Subjects with Exacerbation History
5. Current COPD Maintenance Therapy

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

1. 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.
2. 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.
3. 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.
4. 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)
5. 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.
6. 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).
7. 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.

Primary outcomes:
measure: Mean Annual Rate of Moderate or Severe COPD Exacerbations
timeFrame: Up to 54 weeks
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study
timeFrame: Up to 58 weeks
measure: Mean Number of Serious Adverse Events of Pneumonia During the Study
timeFrame: Up to 58 weeks
measure: Time to the First Serious Adverse Event of Pneumonia Occuring in a Year
timeFrame: Up to 52 weeks
measure: Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean
timeFrame: Up to 54 weeks
measure: Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean
timeFrame: Up to 54 weeks
measure: Number of All Secondary Care Contacts Expressed Using Least Square Mean
timeFrame: Up to 54 weeks
measure: Number of All Primary Care Contacts Expressed Using Least Square Mean
timeFrame: Up to 54 weeks
measure: Time to an Event of Discontinuation of Initial Therapy Occurring in a Year
timeFrame: Up to 364 days
measure: Time to the Addition of a Further COPD Controller Medication Occurring in a Year
timeFrame: Up to 364 days
measure: Time to First Moderate/Severe Exacerbations Occurring in a Year
timeFrame: Up to 364 days
measure: Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year
timeFrame: Up to 364 days
measure: Time to First Severe Exacerbations Occurring in a Year
timeFrame: Up to 364 days
measure: Number of Participants With Fatal Serious Adverse Events of Pneumonia
timeFrame: Upto 58 weeks
measure: Number of Participants With Non-serious Adverse Drug Reactions (ADR)
timeFrame: Up to 54 weeks
measure: Number of Participants With Serious Adverse Events
timeFrame: Up to 56 weeks
measure: Number of Participants With Serious Adverse Drug Reactions
timeFrame: Upto 12 months
Other outcomes:
Locations:
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Bowdon
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Cheadle Hulme
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Cheadle
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Edgeley
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Gatley
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Heald Green
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Sale
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Sale
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Sale
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Sale
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Timperley
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Timperley
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Broadway, Davyhulme
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Irlam
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Newall Green
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Northenden
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Northern Moor
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Pendlebury, Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Pendlebury
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Salford
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Salford
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Salford
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Salford
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Stretford
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Timperley
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Withington
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Wythenshawe
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Wythenshawe
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Wythenshawe
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Cadishead, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Cheadle
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Eccles
country: United Kingdom
facility: GSK Investigational Site
city: Ellenbrook, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Salford
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Salford
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Little Hulton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Pendlebury, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton
country: United Kingdom
facility: GSK Investigational Site
city: Swinton
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Worsley, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Worsley, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Worsley, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Wythenshawe
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bakerly 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.
citation: Sperrin 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.
citation: Bakerly 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.
citation: Woodcock 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.
citation: Vestbo 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.
citation: Bakerly 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.
citation: New 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.