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A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

FF/VI

Existing Maintenance Therapy

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Exacerbation, Adult, COPD, Respiratory

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

FF/VI

Existing Maintenance Therapy

Arm Description

once daily via a Novel Dry Powder Inhaler

Existing Maintenance Therapy: Long acting bronchodilator therapy alone ICS alone or in combination with a long acting bronchodilator Triple maintenance therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study

Incidence of SAE of pneumonia was defined for each randomized treatment group as the proportion (number) of participants in that group who experienced at least one SAE of pneumonia in the Pneumonia Adverse Event of Special Interest subgroup during the treatment period (from start date of exposure to stop date of exposure + 28 days). Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2. Serious Adverse Events of pneumonia are defined by the Pneumonia Special Interest Group, which for SAEs of pneumonia collected for these subjects includes the following preferred terms: Pneumonia, Pneumonia aspiration, Aspergillus infection, Empyema, Pneumonia streptococcal, Pneumonitis, Pulmonary tuberculosis.

Mean Number of Serious Adverse Events of Pneumonia During the Study

The mean number of SAE of pneumonia over the treatment period (from first date of exposure to last date of exposure + 28 days was calculated. Analysis was performed using a negative binomial regression model with covariates of randomised treatment and with logarithm of time on treatment as an offset variable.

Time to the First Serious Adverse Event of Pneumonia Occuring in a Year

The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Analyses included those on-treatment SAEs of pneumonia that had an onset over the first 364 days of exposure, as defined. Participants who did not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to end date of exposure + 28 days were considered censored. Number of participants with event is presented.

Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean

A COPD-related secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an accident & emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. Inpatient admissions recorded at two hospitals on the same day, this was counted as a single (inpatient admission) secondary care contact. COPD-related contacts were identified using predefined lists of ICD-10 codes, specialty descriptions and diagnosis codes recorded in the patients electronic health record (EHR). GLM assuming the negative binomial distribution with log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.

Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean

A COPD-related primary care contact was defined as a primary care contact on a given calendar date with either a nurse, general physician (GP) or other healthcare professional that were considered as COPD-related, if the most prominent signs and symptoms the participant was presenting were as a direct result of the participant's COPD, as per Readcodes recorded in the patients electronic health record (EHR). The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.

Number of All Secondary Care Contacts Expressed Using Least Square Mean

A secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. In the situation where inpatient admissions were recorded at two hospitals on the same day, this was counted as a single secondary care contact. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomization stratification, number of moderate/severe COPD exacerbations in the previous year to randomization and smoking status at baseline.

Number of All Primary Care Contacts Expressed Using Least Square Mean

A primary care contact was defined as contact with a either a nurse, general practitioner, or other healthcare professional. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.

Time to an Event of Discontinuation of Initial Therapy Occurring in a Year

Initial therapy was defined as the treatment that the subject was randomised to at randomisation. Discontinuation of initial therapy was defined as any modification of initial therapy. These included stepping up, stepping down or switching to another class/class combination, or withdrawal from the study. Switching within the same drug class did not count unless participant switched from FF/VI to a different ICS/LABA. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of discontinuation of initial therapy was measured from the date of randomisation (i.e., exposure start date) to the date of discontinuation of initial therapy to which the participant was randomized, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without discontinuing the initial therapy (censored). Number of participants with event is presented.

Time to the Addition of a Further COPD Controller Medication Occurring in a Year

The date of an event for addition of a further COPD controller medication was defined as the exposure start date of the first modified treatment medication that included a new COPD maintenance therapy of a new class of drug (to the initial therapy) during the study treatment period, as collected on the investigational product page of the eCRF. Participants who did not add any COPD controller medication during the study were censored at the end of the treatment period (Day 364). This was equivalent to stepping up, defined as the addition of at least one new class of drug. The probability of an event was measured from the date of randomisation (i.e., treatment initiation) to the date of a change event. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Number of participants with event is presented.

Time to First Moderate/Severe Exacerbations Occurring in a Year

The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of a first moderate / severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first moderate or severe COPD exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any moderate or severe exacerbations (censored). Participants who completed the study without a moderate or severe COPD exacerbation and analyses of time to first moderate/severe exacerbation were censored at Day 364. Number of participants with event is presented.

Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year

The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first moderate / severe exacerbation on initial therapy was measured from the date of randomisation (i.e., exposure start date) to the onset date of first moderate or severe COPD exacerbation, or to the date of discontinuation of initial therapy (analysis was censored at date of discontinuation of initial therapy) for participants who completed the study without any moderate or severe exacerbations on initial therapy. Number of participants with event is presented.

Time to First Severe Exacerbations Occurring in a Year

The date of an event for severe exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe exacerbation were censored. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first severe exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any severe exacerbations (censored). At Day 364, all participants who have not experienced a severe exacerbation are considered censored, regardless of whether their on-treatment phase continues beyond day 364, including those who withdrew early. Number of participants with event is presented.

Number of Participants With Fatal Serious Adverse Events of Pneumonia

All SAEs included in the AE subgroup of special interest of "pneumonia" were considered as an SAE of pneumonias. A fatal SAE was defined as a SAE with outcome of fatal for study participant. The number of participants with fatal SAEs of pneumonia was assessed over 14 months.

Number of Participants With Non-serious Adverse Drug Reactions (ADR)

The number of participants with non-serious ADRs was assessed for up to 54 weeks. An ADR is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. A non-serious ADR included one of the following: exacerbation of chronic or intermittent pre-existing condition; signs, symptoms, or the clinical sequelae of a suspected interaction; signs, symptoms, or new conditions detected or diagnosed after study treatment administration.

Number of Participants With Serious Adverse Events

SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a significant medical event in the investigator's judgment, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. SAEs were includes if the onset date was on or after the treatment start date and on or before the treatment stop date. However, the window for an SAE of pneumonia was longer and included 28 days post study treatment stop date.

Number of Participants With Serious Adverse Drug Reactions

A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Full Information

NCT ID

NCT01551758

First Posted

March 1, 2012

Last Updated

May 3, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01551758

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 13, 2012 (Actual)

Primary Completion Date

November 24, 2015 (Actual)

Study Completion Date

November 24, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Exacerbation, Adult, COPD, Respiratory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2802 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FF/VI

Arm Type

Experimental

Arm Description

once daily via a Novel Dry Powder Inhaler

Arm Title

Existing Maintenance Therapy

Arm Type

Other

Arm Description

Existing Maintenance Therapy: Long acting bronchodilator therapy alone ICS alone or in combination with a long acting bronchodilator Triple maintenance therapy

Intervention Type

Drug

Intervention Name(s)

FF/VI

Intervention Description

FF/VI

Intervention Type

Other

Intervention Name(s)

Existing Maintenance Therapy

Intervention Description

Existing Maintenance Therapy: Long acting bronchodilator therapy alone ICS alone or in combination with a long acting bronchodilator Triple maintenance therapy

Primary Outcome Measure Information:

Title

Mean Annual Rate of Moderate or Severe COPD Exacerbations

Description

Time Frame

Up to 54 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study

Description

Time Frame

Up to 58 weeks

Title

Mean Number of Serious Adverse Events of Pneumonia During the Study

Description

Time Frame

Up to 58 weeks

Title

Time to the First Serious Adverse Event of Pneumonia Occuring in a Year

Description

Time Frame

Up to 52 weeks

Title

Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean

Description

Time Frame

Up to 54 weeks

Title

Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean

Description

Time Frame

Up to 54 weeks

Title

Number of All Secondary Care Contacts Expressed Using Least Square Mean

Description

Time Frame

Up to 54 weeks

Title

Number of All Primary Care Contacts Expressed Using Least Square Mean

Description

Time Frame

Up to 54 weeks

Title

Time to an Event of Discontinuation of Initial Therapy Occurring in a Year

Description

Time Frame

Up to 364 days

Title

Time to the Addition of a Further COPD Controller Medication Occurring in a Year

Description

Time Frame

Up to 364 days

Title

Time to First Moderate/Severe Exacerbations Occurring in a Year

Description

Time Frame

Up to 364 days

Title

Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year

Description

The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first moderate / severe exacerbation on initial therapy was measured from the date of randomisation (i.e., exposure start date) to the onset date of first moderate or severe COPD exacerbation, or to the date of discontinuation of initial therapy (analysis was censored at date of discontinuation of initial therapy) for participants who completed the study without any moderate or severe exacerbations on initial therapy. Number of participants with event is presented.

Time Frame

Up to 364 days

Title

Time to First Severe Exacerbations Occurring in a Year

Description

Time Frame

Up to 364 days

Title

Number of Participants With Fatal Serious Adverse Events of Pneumonia

Description

Time Frame

Upto 58 weeks

Title

Number of Participants With Non-serious Adverse Drug Reactions (ADR)

Description

Time Frame

Up to 54 weeks

Title

Number of Participants With Serious Adverse Events

Description

Time Frame

Up to 56 weeks

Title

Number of Participants With Serious Adverse Drug Reactions

Description

Time Frame

Upto 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Cheshire

ZIP/Postal Code

WA14 2NW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Cheshire

ZIP/Postal Code

WA14 5ET

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Cheshire

ZIP/Postal Code

WA14 5GR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Cheshire

ZIP/Postal Code

WA14 5NH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Cheshire

ZIP/Postal Code

WA14 5PF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bowdon

State/Province

Cheshire

ZIP/Postal Code

WA14 3BD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cheadle Hulme

State/Province

Cheshire

ZIP/Postal Code

SK8 5EG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cheadle

State/Province

Cheshire

ZIP/Postal Code

SK8 6LQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edgeley

State/Province

Cheshire

ZIP/Postal Code

SK3 9LQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Gatley

State/Province

Cheshire

ZIP/Postal Code

SK84NG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Heald Green

State/Province

Cheshire

ZIP/Postal Code

SK8 3QA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Sale

State/Province

Cheshire

ZIP/Postal Code

M33 2RH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Sale

State/Province

Cheshire

ZIP/Postal Code

M33 2UP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Sale

State/Province

Cheshire

ZIP/Postal Code

M33 4BR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Sale

State/Province

Cheshire

ZIP/Postal Code

M33 7SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stockport

State/Province

Cheshire

ZIP/Postal Code

SK3 9NX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Timperley

State/Province

Cheshire

ZIP/Postal Code

WA15 7DD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Timperley

State/Province

Cheshire

ZIP/Postal Code

WA15 7UN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Greater Manchester

ZIP/Postal Code

WA14 2DW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Altrincham

State/Province

Greater Manchester

ZIP/Postal Code

WA15 6PH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Broadway, Davyhulme

State/Province

Greater Manchester

ZIP/Postal Code

M41 7WJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M44 5LH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam

State/Province

Greater Manchester

ZIP/Postal Code

M44 5LH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 1EB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 2DN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 2RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 3BG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 6WF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M22 4DH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M22 5DW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M22 5RB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M22 5RX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M22 9UE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M23 1JP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M23 1JX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M23 9AB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M27 9LB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M32 0DF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M32 0PA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M32 0RW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 2TB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 3HF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 4WB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 5JD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 5PN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 7SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M33 7XN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 0NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 0SE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 0TZ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 5AA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 7FN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 7WJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M41 8AA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

WA15 6BP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

WA15 7UN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newall Green

State/Province

Greater Manchester

ZIP/Postal Code

M23 2SY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Northenden

State/Province

Greater Manchester

ZIP/Postal Code

M22 4DH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Northern Moor

State/Province

Greater Manchester

ZIP/Postal Code

M23 0BX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Pendlebury, Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M27 8HP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Pendlebury

State/Province

Greater Manchester

ZIP/Postal Code

M27 8HP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M7 4TP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

State/Province

Greater Manchester

ZIP/Postal Code

M6 5PW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

State/Province

Greater Manchester

ZIP/Postal Code

M6 6ES

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

State/Province

Greater Manchester

ZIP/Postal Code

M6 7HL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

State/Province

Greater Manchester

ZIP/Postal Code

M7 1RD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stretford

State/Province

Greater Manchester

ZIP/Postal Code

M32 9BD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Timperley

State/Province

Greater Manchester

ZIP/Postal Code

WA15 6PH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Withington

State/Province

Greater Manchester

ZIP/Postal Code

M20 1EY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wythenshawe

State/Province

Greater Manchester

ZIP/Postal Code

M22 0EP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wythenshawe

State/Province

Greater Manchester

ZIP/Postal Code

M22 5RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wythenshawe

State/Province

Greater Manchester

ZIP/Postal Code

M22 5RX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cadishead, Manchester

ZIP/Postal Code

M44 5DD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cheadle

ZIP/Postal Code

SK8 5BB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 0EA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 0EJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 0LS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 0NU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 0PF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 0TU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 7JW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 7NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 8AR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 8JA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 8QD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles, Manchester

ZIP/Postal Code

M30 9PS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Eccles

ZIP/Postal Code

M30 0TU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Ellenbrook, Manchester

ZIP/Postal Code

M28 1PB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Manchester

ZIP/Postal Code

M44 5LH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Manchester

ZIP/Postal Code

M44 6AJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Manchester

ZIP/Postal Code

M44 6BL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Manchester

ZIP/Postal Code

M44 6FE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Manchester

ZIP/Postal Code

M44 6FN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Salford

ZIP/Postal Code

M44 6DP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Irlam, Salford

ZIP/Postal Code

M44 6ZS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M28 0AY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M28 0BA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M38 9GH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M38 9GR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M38 9LQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M38 9RS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Little Hulton, Manchester

ZIP/Postal Code

M38 9WX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M20 4SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M22 4HD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M22 4QN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M23 1JX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M28 1PB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M32 8AQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M32 9PA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M33 3JS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M33 4DX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M33 7XZ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 5BG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 7AB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 8GY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 8TW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 9FD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 9NU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M41 9SB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M7 4PF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Pendlebury, Manchester

ZIP/Postal Code

M27 6EW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M3 6AF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M3 6BY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M5 3TP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M5 4QU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M5 5HJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M5 5JR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 5FX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 5JA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 5JS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 5PH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 5WN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 5WW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 7GU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 7HL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 8HA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 8LE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M6 8NR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M7 1QE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M7 1RD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M7 1UD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M7 3SE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M7 4AE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford, Manchester

ZIP/Postal Code

M7 4AS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M5 3PH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M5 4BS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 3PH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 5FX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 5JG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 5PP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 5QQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 6ES

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M7 3SE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M7 4LZ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M7 4NX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M7 4UF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stockport

ZIP/Postal Code

SK2 7EY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stockport

ZIP/Postal Code

SK3 9AD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stockport

ZIP/Postal Code

SK8 3JD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stockport

ZIP/Postal Code

SK8 3QA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Stockport

ZIP/Postal Code

SK8 5LL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swinton, Manchester

ZIP/Postal Code

M27 0EW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swinton, Manchester

ZIP/Postal Code

M27 0NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swinton, Manchester

ZIP/Postal Code

M27 4AF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swinton, Manchester

ZIP/Postal Code

M27 4BH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swinton

ZIP/Postal Code

M27 4BJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swinton

ZIP/Postal Code

M27 8HP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Walkden, Manchester

ZIP/Postal Code

M28 3AT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Walkden, Manchester

ZIP/Postal Code

M28 3BT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Walkden, Manchester

ZIP/Postal Code

M28 3DR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Walkden, Manchester

ZIP/Postal Code

M28 3EZ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Walkden, Manchester

ZIP/Postal Code

M28 3ZD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Walkden, Manchester

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Worsley, Manchester

ZIP/Postal Code

M28 1FB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Worsley, Manchester

ZIP/Postal Code

M28 1LZ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Worsley, Manchester

ZIP/Postal Code

M28 3AT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wythenshawe

ZIP/Postal Code

M22 0LA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

35273031

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.

Results Reference

derived

PubMed Identifier

33781142

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.

Results Reference

derived

PubMed Identifier

31385428

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.

Results Reference

derived

PubMed Identifier

30704700

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.

Results Reference

derived

PubMed Identifier

29467200

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.

Results Reference

derived

PubMed Identifier

27593504

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.

Results Reference

derived

PubMed Identifier

26337978

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.

Results Reference

derived

PubMed Identifier

24603195

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. Erratum In: Thorax. 2015 Oct;70(10):1008.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115151

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)

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A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial