Overview

This trial is active, not recruiting.

Condition asthma
Treatments fluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
Phase phase 3
Sponsor GlaxoSmithKline
Start date November 2012
End date December 2016
Trial size 4036 participants
Trial identifier NCT01706198, 115150

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
fluticasone furoate + vilanterol
once daily via a Novel Dry Powder Inhaler
inhaled corticosteroid with or without a long acting beta2-agonist
ICS alone or in combination with a long acting bronchodilator
(Active Comparator)
inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)
inhaled corticosteroid with or without a long acting beta2-agonist
ICS alone or in combination with a long acting bronchodilator

Primary Outcomes

Measure
The percentage of subjects who have an ACT total score of ≥ 20 at Week 24 (6th month) assessment.
time frame: week 24

Secondary Outcomes

Measure
Percentage of subjects with asthma control (ACT total score ≥ 20)
time frame: Weeks 12, 40 and 52
Mean change from baseline in ACT total score
time frame: Weeks 12, 24, 40 and 52
Percentage of subjects who have an increase from baseline of ≥ 3 in ACT total score
time frame: Weeks 12, 24, 40 and 52
Asthma-related secondary care contacts
time frame: 12 months
Asthma-related primary care contacts
time frame: 12 months
All secondary care contacts
time frame: 12 months
All primary care contacts
time frame: 12 months
Mean annual rate of severe asthma exacerbations
time frame: 12 months
Number of salbutamol inhalers (adjusted to equivalence of 200 actuations) collected by the subjects from study-enrolled community pharmacies over the entire treatment period
time frame: 12 months
Time to discontinuation or modification of initial therapy
time frame: 12 months
Percentage of subjects who have an increase from baseline of ≥ 0.5 in AQLQ(S) total score at Week 52
time frame: Week 52
Percentage of subjects who have an increase from baseline of ≥ 0.5 in AQLQ(S) environmental stimuli domain score at Week 52
time frame: Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.