Last updated: 11/07/2018 09:52:03
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared with Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects with COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once-Daily via a Novel Dry Powder Inhaler Compared with Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily via the HandiHaler in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Disease
Trial description: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline trough in 24-hour weighted mean FEV1 on Treatment Day 84
Timeframe: Baseline and Day 84
Secondary outcomes:
Time to onset on Treatment Day 1
Timeframe: Baseline and Day 1
Change from Baseline in trough FEV1 at Treatment Day 84
Timeframe: Baseline and Day 84
Interventions:
Enrollment:
623
Primary completion date:
2012-21-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Covelli H, Pek B, Schenkenberger I, Scott-Wilson C, Emmett A, Crim C.Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk.Int J Chron Obstruct Pulmon Dis.2015;11:1-12.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
April 2012 to December 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Signed and dated written informed consent
- Male or females ≥ 40 years of age
- Current diagnosis of asthma
- Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Inclusion and exclusion criteria
Inclusion criteria:
- Signed and dated written informed consent
- Male or females ≥ 40 years of age
- Females must be post-menopausal or using a highly effective method for avoidance of pregnancy
- Established clinical history of COPD by ATS/ERS definition
- Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)
- Former or current smoker ≥10 pack years
- A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:
- Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)
- Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)
- Previous stroke
- Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)
- Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary) OR
- Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):
- Current diagnosis of hypertension
- Current diagnosis of hypercholesterolemia
- Diabetes mellitus treated with pharmacotherapy
Exclusion criteria:
- Current diagnosis of asthma
- Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Lung volume reduction surgery within previous 12 months
- Clinically significant abnormalities not due to COPD by chest X-ray or CT scan
- Hospitalized for poorly controlled COPD within 12 weeks of Screening
- Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
- Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
- A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period
- An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization
- An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization
- An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)
- Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities
- Carcinoma not in complete remission for at least 5 years
- History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject’s participation will also be excluded
- Known/suspected history of alcohol or drug abuse in the last 2 years
- Women who are pregnant or lactating or plan to become pregnant
- Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit
- Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
- Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
- Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments
- Non-compliance or inability to comply with study procedures or scheduled visits
- History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
- Affiliation with investigator site
- Women who are pregnant or lactating or are planning on becoming pregnant during the study
Trial location(s)
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5V 2T3
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-21-12
Actual study completion date
2012-21-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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