Clinical trial NCT01706198: An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
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 Compared With Usual Maintenance Therapy in Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: respiratory
adult
asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 4233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) 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.

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

Eligibility criteria: Inclusion Criteria:

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

1. Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated.
2. Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease.
3. 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
4. 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).
5. 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
6. 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:

1. 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.
2. COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease.
3. 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.
4. 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.
5. 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)
6. 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)
7. Subjects who are using LABA without an ICS as asthma maintenance therapy.
8. Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area.

Primary outcomes:
measure: 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.
timeFrame: Baseline (Day 0) and Week 24
Secondary outcomes:
measure: 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.
timeFrame: Baseline (Day 0) and Weeks 12, 40 and 52
measure: Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
timeFrame: Weeks 12, 24, 40 and 52
measure: Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
timeFrame: Baseline (Day 0) and Weeks 12, 24, 40 and 52
measure: Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
timeFrame: Baseline (Day 0) and Weeks 12, 24, 40 and 52
measure: Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
timeFrame: Weeks 12, 24, 40 and 52
measure: Annual Rate of Asthma-related Secondary Care Contacts
timeFrame: Up to Week 52
measure: Annual Rate of Asthma-related Primary Care Contacts
timeFrame: Up to Week 52
measure: Number of Participants With Time to First Asthma-related Primary Care Contact
timeFrame: Up to Week 52
measure: Annual Rate of All On-treatment Secondary Care Contacts
timeFrame: Up to Week 52
measure: Annual Rate of All On-treatment Primary Care Contacts
timeFrame: Up to Week 52
measure: Number of Participants With Time to First Primary Care Contact
timeFrame: Up to Week 52
measure: Mean Annual Rate of Severe Asthma Exacerbations
timeFrame: Up to Week 52
measure: Time to First Severe Asthma Exacerbation.
timeFrame: Up to Week 52
measure: Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.
timeFrame: Up to 12 months
measure: Time to Modification of Initial Therapy
timeFrame: Up to Week 52
measure: 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.
timeFrame: Baseline (Day 0) and Week 52
measure: Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.
timeFrame: Baseline (Day 0) and Week 52
measure: Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia
timeFrame: Up to Week 52
measure: Time to First SAE of Pneumonia
timeFrame: Up to Week 52
measure: Number of Participants With Fatal SAEs of Pneumonia
timeFrame: Up to Week 52
measure: Number of Participants With SAEs
timeFrame: Up to Week 52
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Altrincham
country: United Kingdom
facility: GSK Investigational Site
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state: Greater Manchester
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state: Greater Manchester
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city: Eccles, Manchester
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city: Eccles, Manchester
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city: Eccles, Manchester
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city: Irlam, Manchester
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city: Irlam, Manchester
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city: Irlam, Manchester
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city: Irlam, Manchester
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city: Irlam, Salford
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city: Little Hulton, Manchester
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facility: GSK Investigational Site
city: Little Hulton, Manchester
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facility: GSK Investigational Site
city: Little Hulton, Manchester
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city: Little Hulton, Manchester
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city: Manchester
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facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
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facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
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city: Manchester
country: United Kingdom
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city: Manchester
country: United Kingdom
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city: Pendlebury, Manchester
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facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Stockport
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Swinton
country: United Kingdom
facility: GSK Investigational Site
city: Swinton
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Walkden, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Worsley, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Worsley, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Worsley, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Wythenshawe
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Woodcock A, Janson C, Rees J, Frith L, Lofdahl M, Moore A, Hedberg M, Leather D. Effects of switching from a metered dose inhaler to a dry powder inhaler on climate emissions and asthma control: post-hoc analysis. Thorax. 2022 Dec;77(12):1187-1192. doi: 10.1136/thoraxjnl-2021-218088. Epub 2022 Feb 7.
citation: Kosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, Svedsater H. Psychometric properties of the Asthma Control Test in 2 randomized clinical trials. J Allergy Clin Immunol Pract. 2021 Jan;9(1):561-563.e1. doi: 10.1016/j.jaip.2020.07.040. Epub 2020 Aug 6. No abstract available.
citation: Svedsater H, Jones R, Bosanquet N, Jacques L, Lay-Flurrie J, Leather DA, Vestbo J, Collier S, Woodcock A. Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study. Respir Med. 2018 Aug;141:198-206. doi: 10.1016/j.rmed.2018.06.003. Epub 2018 Jun 6.
citation: Jacques L, Bakerly ND, New JP, Svedsater H, Lay-Flurrie J, Leather DA. Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study. J Asthma. 2019 Jul;56(7):748-757. doi: 10.1080/02770903.2018.1490751. Epub 2018 Oct 16.
citation: Woodcock A, Vestbo J, Bakerly ND, New J, Gibson JM, McCorkindale S, Jones R, Collier S, Lay-Flurrie J, Frith L, Jacques L, Fletcher JL, Harvey C, Svedsater H, Leather D; Salford Lung Study Investigators. Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial. Lancet. 2017 Nov 18;390(10109):2247-2255. doi: 10.1016/S0140-6736(17)32397-8. Epub 2017 Sep 10.
citation: Woodcock A, Bakerly ND, New JP, Gibson JM, Wu W, Vestbo J, Leather D. The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma. BMC Pulm Med. 2015 Dec 10;15:160. doi: 10.1186/s12890-015-0150-8.
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.