An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma

July 26, 2018 updated by: GlaxoSmithKline

A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler Compared With Usual Maintenance Therapy in Subjects With Asthma

This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

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 asthma in a localised geographical region of the UK

Study Type

Interventional

Enrollment (Actual)

4233

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Cadishead, Manchester, United Kingdom, M44 5DD
    - GSK Investigational Site
  - Cheadle, United Kingdom, SK8 5BB
    - GSK Investigational Site
  - Eccles, United Kingdom, M30 0TU
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 0EA
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 0EJ
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 0LS
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 0NU
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 0PF
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 0TU
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 7JW
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 7NA
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 8AR
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 8JA
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 8QD
    - GSK Investigational Site
  - Eccles, Manchester, United Kingdom, M30 9PS
    - GSK Investigational Site
  - Ellenbrook, Manchester, United Kingdom, M28 1PB
    - GSK Investigational Site
  - Irlam, Manchester, United Kingdom, M44 5LH
    - GSK Investigational Site
  - Irlam, Manchester, United Kingdom, M44 6AJ
    - GSK Investigational Site
  - Irlam, Manchester, United Kingdom, M44 6BL
    - GSK Investigational Site
  - Irlam, Manchester, United Kingdom, M44 6FE
    - GSK Investigational Site
  - Irlam, Manchester, United Kingdom, M44 6FN
    - GSK Investigational Site
  - Irlam, Salford, United Kingdom, M44 6ZS
    - GSK Investigational Site
  - Little Hulton, Manchester, United Kingdom, M28 0AY
    - GSK Investigational Site
  - Little Hulton, Manchester, United Kingdom, M28 0BA
    - GSK Investigational Site
  - Little Hulton, Manchester, United Kingdom, M38 9GR
    - GSK Investigational Site
  - Little Hulton, Manchester, United Kingdom, M38 9LQ
    - GSK Investigational Site
  - Little Hulton, Manchester, United Kingdom, M38 9RS
    - GSK Investigational Site
  - Little Hulton, Manchester, United Kingdom, M38 9WX
    - GSK Investigational Site
  - Manchester, United Kingdom, M28 1PB
    - GSK Investigational Site
  - Manchester, United Kingdom, M16 0WL
    - GSK Investigational Site
  - Manchester, United Kingdom, M20 4SS
    - GSK Investigational Site
  - Manchester, United Kingdom, M22 4HD
    - GSK Investigational Site
  - Manchester, United Kingdom, M22 4QN
    - GSK Investigational Site
  - Manchester, United Kingdom, M22 9UH
    - GSK Investigational Site
  - Manchester, United Kingdom, M23 1JX
    - GSK Investigational Site
  - Manchester, United Kingdom, M23 9AB
    - GSK Investigational Site
  - Manchester, United Kingdom, M32 0RN
    - GSK Investigational Site
  - Manchester, United Kingdom, M32 8AQ
    - GSK Investigational Site
  - Manchester, United Kingdom, M32 9PA
    - GSK Investigational Site
  - Manchester, United Kingdom, M33 3JS
    - GSK Investigational Site
  - Manchester, United Kingdom, M33 4DX
    - GSK Investigational Site
  - Manchester, United Kingdom, M33 7XZ
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 5BG
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 7AB
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 7ZA
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 8GY
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 8TW
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 9FD
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 9NU
    - GSK Investigational Site
  - Manchester, United Kingdom, M41 9SB
    - GSK Investigational Site
  - Manchester, United Kingdom, M7 4PF
    - GSK Investigational Site
  - Manchester, United Kingdom, WA14 1RH
    - GSK Investigational Site
  - Manchester, United Kingdom, WA14 4LJ
    - GSK Investigational Site
  - Manchester, United Kingdom, WA15 9SZ
    - GSK Investigational Site
  - Pendlebury, Manchester, United Kingdom, M27 6EW
    - GSK Investigational Site
  - Salford, United Kingdom, M5 3PH
    - GSK Investigational Site
  - Salford, United Kingdom, M5 4BS
    - GSK Investigational Site
  - Salford, United Kingdom, M6 3PH
    - GSK Investigational Site
  - Salford, United Kingdom, M6 5FX
    - GSK Investigational Site
  - Salford, United Kingdom, M6 5JG
    - GSK Investigational Site
  - Salford, United Kingdom, M6 5PP
    - GSK Investigational Site
  - Salford, United Kingdom, M6 5QQ
    - GSK Investigational Site
  - Salford, United Kingdom, M6 6ES
    - GSK Investigational Site
  - Salford, United Kingdom, M7 3SE
    - GSK Investigational Site
  - Salford, United Kingdom, M7 4UF
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M3 6AF
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M3 6BY
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M5 3TP
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M5 4QU
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M5 5HJ
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M5 5JR
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5FX
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5JA
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5JS
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5PH
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5PW
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5WN
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 5WW
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 7GU
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 7HL
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 8HA
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 8LE
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M6 8NR
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M7 1QE
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M7 1RD
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M7 1UD
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M7 3SE
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M7 4AE
    - GSK Investigational Site
  - Salford, Manchester, United Kingdom, M7 4AS
    - GSK Investigational Site
  - Stockport, United Kingdom, SK2 7EY
    - GSK Investigational Site
  - Stockport, United Kingdom, SK3 9AD
    - GSK Investigational Site
  - Stockport, United Kingdom, SK8 3JD
    - GSK Investigational Site
  - Stockport, United Kingdom, SK8 3QA
    - GSK Investigational Site
  - Stockport, United Kingdom, SK8 5LL
    - GSK Investigational Site
  - Swinton, United Kingdom, M27 8HP
    - GSK Investigational Site
  - Swinton, United Kingdom, M27 4BJ
    - GSK Investigational Site
  - Swinton, Manchester, United Kingdom, M27 0EW
    - GSK Investigational Site
  - Swinton, Manchester, United Kingdom, M27 0NA
    - GSK Investigational Site
  - Swinton, Manchester, United Kingdom, M27 4AF
    - GSK Investigational Site
  - Swinton, Manchester, United Kingdom, M27 4BH
    - GSK Investigational Site
  - Walkden, Manchester, United Kingdom, M28 3AT
    - GSK Investigational Site
  - Walkden, Manchester, United Kingdom, M28 3BT
    - GSK Investigational Site
  - Walkden, Manchester, United Kingdom, M28 3DR
    - GSK Investigational Site
  - Walkden, Manchester, United Kingdom, M28 3ZD
    - GSK Investigational Site
  - Walkden, Manchester, United Kingdom
    - GSK Investigational Site
  - Worsley, Manchester, United Kingdom, M28 1FB
    - GSK Investigational Site
  - Worsley, Manchester, United Kingdom, M28 1LZ
    - GSK Investigational Site
  - Worsley, Manchester, United Kingdom, M28 3AT
    - GSK Investigational Site
  - Wythenshawe, United Kingdom, M22 0LA
    - GSK Investigational Site
- Cheshire
  - Altrincham, Cheshire, United Kingdom, WA14 2NW
    - GSK Investigational Site
  - Altrincham, Cheshire, United Kingdom, WA14 5ET
    - GSK Investigational Site
  - Altrincham, Cheshire, United Kingdom, WA14 5GR
    - GSK Investigational Site
  - Altrincham, Cheshire, United Kingdom, WA14 5NH
    - GSK Investigational Site
  - Altrincham, Cheshire, United Kingdom, WA14 5PF
    - GSK Investigational Site
  - Bowdon, Cheshire, United Kingdom, WA14 3BD
    - GSK Investigational Site
  - Cheadle, Cheshire, United Kingdom, SK8 6LQ
    - GSK Investigational Site
  - Cheadle Hulme, Cheshire, United Kingdom, SK8 5EG
    - GSK Investigational Site
  - Edgeley, Cheshire, United Kingdom, SK3 9LQ
    - GSK Investigational Site
  - Gatley, Cheshire, United Kingdom, SK84NG
    - GSK Investigational Site
  - Heald Green, Cheshire, United Kingdom, SK8 3QA
    - GSK Investigational Site
  - Sale, Cheshire, United Kingdom, M33 2RH
    - GSK Investigational Site
  - Sale, Cheshire, United Kingdom, M33 2UP
    - GSK Investigational Site
  - Sale, Cheshire, United Kingdom, M33 4BR
    - GSK Investigational Site
  - Sale, Cheshire, United Kingdom, M33 7SS
    - GSK Investigational Site
  - Stockport, Cheshire, United Kingdom, SK3 9NX
    - GSK Investigational Site
  - Timperley, Cheshire, United Kingdom, WA15 7DD
    - GSK Investigational Site
  - Timperley, Cheshire, United Kingdom, WA15 7UN
    - GSK Investigational Site
- Greater Manchester
  - Altrincham, Greater Manchester, United Kingdom, WA14 2DW
    - GSK Investigational Site
  - Altrincham, Greater Manchester, United Kingdom, WA15 6PH
    - GSK Investigational Site
  - Broadway, Davyhulme, Greater Manchester, United Kingdom, M41 7WJ
    - GSK Investigational Site
  - Irlam, Greater Manchester, United Kingdom, M44 5LH
    - GSK Investigational Site
  - Irlam, Manchester, Greater Manchester, United Kingdom, M44 5LH
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M22 4DH
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M20 2RN
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M20 1EB
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M20 2DN
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M20 3BG
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M20 4SS
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M20 6WF
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M22 5DW
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M22 5RB
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M22 5RX
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M22 9UE
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M23 1JP
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M23 1JX
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M23 9AB
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M27 9LB
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M32 0DF
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M32 0PA
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M32 0RW
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 2TB
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 3HF
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 4WB
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 5JD
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 5PN
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 7SS
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M33 7XN
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 0NA
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 0SE
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 0TZ
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 5AA
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 7FN
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 7WJ
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, M41 8AA
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, WA15 6BP
    - GSK Investigational Site
  - Manchester, Greater Manchester, United Kingdom, WA15 7UN
    - GSK Investigational Site
  - Newall Green, Greater Manchester, United Kingdom, M23 2SY
    - GSK Investigational Site
  - Northenden, Greater Manchester, United Kingdom, M22 4DH
    - GSK Investigational Site
  - Northern Moor, Greater Manchester, United Kingdom, M23 0BX
    - GSK Investigational Site
  - Pendlebury, Greater Manchester, United Kingdom, M27 8HP
    - GSK Investigational Site
  - Salford, Greater Manchester, United Kingdom, M6 7HL
    - GSK Investigational Site
  - Salford, Greater Manchester, United Kingdom, M7 1RD
    - GSK Investigational Site
  - Salford, Manchester, Greater Manchester, United Kingdom, M6 6ES
    - GSK Investigational Site
  - Salford, Manchester, Greater Manchester, United Kingdom, M7 4TP
    - GSK Investigational Site
  - Stretford, Greater Manchester, United Kingdom, M32 9BD
    - GSK Investigational Site
  - Timperley, Greater Manchester, United Kingdom, WA15 6PH
    - GSK Investigational Site
  - Withington, Greater Manchester, United Kingdom, M20 1EY
    - GSK Investigational Site
  - Wythenshawe, Greater Manchester, United Kingdom, M22 0EP
    - GSK Investigational Site
  - Wythenshawe, Greater Manchester, United Kingdom, M22 5RN
    - GSK Investigational Site
  - Wythenshawe, Greater Manchester, United Kingdom, M22 5RX
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated.
Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease.
Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2.
- Other background asthma medication such as anti-leukotrienes are permitted
All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject's recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines).
Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf
Gender and Age: Male or female subjects aged ≥18 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of:
- Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<147 pmol/L) is confirmatory.

OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - Visit 2 to the end of the study).

Exclusion Criteria:

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

Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months.
COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease.
Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded.
Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening)
Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening)
Subjects who are using LABA without an ICS as asthma maintenance therapy.
Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FF/VI fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler	Drug: fluticasone furoate + vilanterol once daily via a Novel Dry Powder Inhaler Drug: inhaled corticosteroid with or without a long acting beta2-agonist ICS alone or in combination with a long acting bronchodilator
Active Comparator: ICS or ICS/LABA maintenance therapy inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)	Drug: inhaled corticosteroid with or without a long acting beta2-agonist ICS alone or in combination with a long acting bronchodilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. Time Frame: Baseline (Day 0) and Week 24	The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of <20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented	Baseline (Day 0) and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52. Time Frame: Baseline (Day 0) and Weeks 12, 40 and 52	The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).	Baseline (Day 0) and Weeks 12, 40 and 52
Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52. Time Frame: Weeks 12, 24, 40 and 52	The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score >=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).	Weeks 12, 24, 40 and 52
Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52. Time Frame: Baseline (Day 0) and Weeks 12, 24, 40 and 52	The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score >=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).	Baseline (Day 0) and Weeks 12, 24, 40 and 52
Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52. Time Frame: Baseline (Day 0) and Weeks 12, 24, 40 and 52	The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).	Baseline (Day 0) and Weeks 12, 24, 40 and 52
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52. Time Frame: Weeks 12, 24, 40 and 52	The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is >=20, 16 to 19 and <=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).	Weeks 12, 24, 40 and 52
Annual Rate of Asthma-related Secondary Care Contacts Time Frame: Up to Week 52	All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.	Up to Week 52
Annual Rate of Asthma-related Primary Care Contacts Time Frame: Up to Week 52	All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.	Up to Week 52
Number of Participants With Time to First Asthma-related Primary Care Contact Time Frame: Up to Week 52	Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.	Up to Week 52
Annual Rate of All On-treatment Secondary Care Contacts Time Frame: Up to Week 52	A secondary care contact is 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. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.	Up to Week 52
Annual Rate of All On-treatment Primary Care Contacts Time Frame: Up to Week 52	All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.	Up to Week 52
Number of Participants With Time to First Primary Care Contact Time Frame: Up to Week 52	Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.	Up to Week 52
Mean Annual Rate of Severe Asthma Exacerbations Time Frame: Up to Week 52	A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.	Up to Week 52
Time to First Severe Asthma Exacerbation. Time Frame: Up to Week 52	A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.	Up to Week 52
Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period. Time Frame: Up to 12 months	Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.	Up to 12 months
Time to Modification of Initial Therapy Time Frame: Up to Week 52	Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.	Up to Week 52
Percentage of Participants Who Have an Increase From Baseline of >=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52. Time Frame: Baseline (Day 0) and Week 52	The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.	Baseline (Day 0) and Week 52
Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52. Time Frame: Baseline (Day 0) and Week 52	The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.	Baseline (Day 0) and Week 52
Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia Time Frame: Up to Week 52	A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of "pneumonia". The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.	Up to Week 52
Time to First SAE of Pneumonia Time Frame: Up to Week 52	An SAE of pneumonia was defined as any SAE in the AESI group of "pneumonia". The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.	Up to Week 52
Number of Participants With Fatal SAEs of Pneumonia Time Frame: Up to Week 52	All SAEs included in the AESI group of "pneumonia" were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.	Up to Week 52
Number of Participants With SAEs Time Frame: Up to Week 52	An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.	Up to Week 52
Number of Participants With Adverse Drug Reactions (ADRs) Time Frame: Up to Week 52	An ADR is any untoward medical occurrence in a clinical investigation participant, 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. ADRs are a subset of AEs for a given medicinal product.	Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

IPD for this study will be made available via the Clinical Study Data Request site.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

115150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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What is the study measuring?

Primary Outcome Measures

Outcome Measure

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Collaborators and Investigators

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Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

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