Study to evaluate the effectiveness of fluticasone furoate/vilanterol delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with existing COPD maintenance therapy alone in subjects with Chronic Obstructive Pulmonary Disease.
- Conditions
- Subjects with Chronic Obstructive Pulmonary Disease (COPD).MedDRA version: 18.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-002452-13-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3161
1. Type of subject: Subjects with documented GP diagnosis of COPD, and currently receiving maintenance therapy
2. 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.
3. 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 pregancy test at Visit 2, and agrees to use one of the contraceptions methods listed in Appendix for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Females subjects must agree to use contraception until completion of the follow-up visit
4. Exacerbation History: Subjects who have a history of treatment with systemic/ oral corticosteroids, antibiotics and/or hospitalisation for at least one COPD exacerbation in the 3 years prior to Visit 1. This will be captured through subject recall and/or the subject’s EMR. Prior use of systemic/oral corticosteroids and/or antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD.
5. Current COPD Therapy
All subjects currently receiving either
• an inhaled corticosteroid (ICS) alone or in combination with a long acting bronchodilator (this could be a fixed dose combination or an ICS/LABA provided in two separate inhalers, or ICS and LAMA),
• or long-acting bronchodilator therapy alone (e.g. tiotropium or salmeterol, or the use of two bronchodilators i.e. LABA/LAMA),
• or triple therapy” i.e. ICS/LABA plus a Long Acting Muscarinic Antagonist (LAMA),
Deviations from inclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety, therefore, adherence to the criteria as specified in the protocol is essential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1798
1. 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
2. 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
3. Subjects with unstable COPD. Patients with an exacerbation (defined by treatment with oral corticosteroids and/or antibiotic) with an onset within 2 weeks of V2 must not be randomised. Randomisation should be delayed until at least 2 weeks after the onset of an exacerbation and until the exacerbation has resolved
4. 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)
5. 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
6. 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)
7. 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 and South Manchester area
8. Subjects whose current medications include RELVAR are not eligible to enter the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method