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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01706198
First received: October 4, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: fluticasone furoate + vilanterol
Drug: inhaled corticosteroid with or without a long acting beta2-agonist
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The percentage of subjects who have an ACT total score of ≥ 20 at Week 24 (6th month) assessment. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    the percentage of subjects who have an ACT totalscore of ≥ 20 at Week 24 (6th month) assessment.


Secondary Outcome Measures:
  • Percentage of subjects with asthma control (ACT total score ≥ 20) [ Time Frame: Weeks 12, 40 and 52 ] [ Designated as safety issue: No ]
    Percentage of subjects with asthma control (ACT total score ≥ 20)

  • Mean change from baseline in ACT total score [ Time Frame: Weeks 12, 24, 40 and 52 ] [ Designated as safety issue: No ]
    Mean change from baseline in ACT total score

  • Percentage of subjects who have an increase from baseline of ≥ 3 in ACT total score [ Time Frame: Weeks 12, 24, 40 and 52 ] [ Designated as safety issue: No ]
    Percentage of subjects who have an increase from baseline of ≥ 3 in ACT total score

  • Asthma-related secondary care contacts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Asthma-related secondary care contacts

  • Asthma-related primary care contacts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Asthma-related primary care contacts

  • All secondary care contacts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    All secondary care contacts

  • All primary care contacts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    All primary care contacts

  • Mean annual rate of severe asthma exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean annual rate of severe asthma exacerbations

  • 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 ] [ Designated as safety issue: No ]
    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 to discontinuation or modification of initial therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to discontinuation or modification of initial therapy

  • Percentage of subjects who have an increase from baseline of ≥ 0.5 in AQLQ(S) total score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Percentage of subjects who have an increase from baseline of ≥ 0.5 in AQLQ(S) total score at 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 ] [ Designated as safety issue: No ]
    Percentage of subjects who have an increase from baseline of ≥ 0.5 in AQLQ(S) environmental stimuli domain score at Week 52.


Estimated Enrollment: 4036
Study Start Date: November 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706198

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 120 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01706198     History of Changes
Other Study ID Numbers: 115150
Study First Received: October 4, 2012
Last Updated: October 9, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
adult
respiratory
asthma

Additional relevant MeSH terms:
Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on October 16, 2014