Last updated: 11/08/2018 17:06:39
A 24-week arterial stiffness study with fluticasone furoate/vilanterol in COPD
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 24-week study to evaluate the effect of fluticasone furoate/vilanterol 100/25 mcg Inhalation Powder delivered once-daily via a Novel Dry Powder Inhaler on arterial stiffness compared with placebo and vilanterol in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Trial description: The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the end of the 24-week Treatment Period (Day 168)
Timeframe: BL to Day 168
Secondary outcomes:
Change from BL in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Day 168
Timeframe: BL to Day 168
Mean number of occasions rescue medication [albuterol (salbutamol)] used during a 24-hour period averaged over the entire 24-week Treatment Period
Timeframe: BL (Week -1), Week 1 to Week 24
Interventions:
Enrollment:
446
Primary completion date:
2014-04-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Surya P. Bhatt, Mark T. Dransfield, John R. Cockcroft, Jie Wang-Jairaj, Dawn A. Midwinter, David B. Rubin, Catherine A. Scott-Wilson, Courtney Crim. A randomized trial of once-daily fluticasone furoate/vilanterol or vilanterol versus placebo to determine effects on arterial stiffness in COPD. Int J Chron Obstruct Pulmon Dis. 2017;12:351-365.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
March 2011 to November 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- COPD diagnosis defined by ATS/ERS
- Former or current smoker
- Pregnancy
- A current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- COPD diagnosis defined by ATS/ERS
- Former or current smoker
- A measured aortic pulse wave velocity = or > 11.0 m/s at Screening
Exclusion criteria:
- Pregnancy
- A current diagnosis of asthma
- alpha1-antitrypsin deficiency as the underlying cause of COPD
- subjects with other and active respiratory disorders
- A cardiovascular event occurred in the 6 months prior to Visit 1
- Current severe heart failure (New York Heart Association Class IV) and have a known ejection fraction of < 30 %
- Clinical significant and uncontrolled hypertension
- Abnormal and clinical significant 12-lead ECG findings at Visit 1
- Have lung volume reduction or lung transplantation within 12 months prior to Visit 1
- Poorly controlled COPD: Acute worsening of COPD that is managed by subject with antibiotics or corticosteroids, or requires treatment prescribed by a physician in the 6 weeks prior to Visit 1; or subject needs to be hospitalised due to poorly controlled COPD within 12 weeks prior to Visit 1
- Lower respiratory tract infection that required use of antibiotics within 6 weeks prior to Visit 1
- Participate in the acute phase of a pulmonary rehabilitation within 4 weeks prior to Visit 1 or who will enter the acute phase of pulmonary rehabilitation during the study.
- Other diseases or abnormalities in the opinion of the investigator would put safety of the subject at risk through participation; or would affect the safety or efficacy analysis if the disease/condition exacerbated during the study.
- subjects with carcinoma has not been in complete remission for at least 5 years. Carcinoma in site of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
- subjects with a history of hypersensitivity to any of the study medications or components of the inhalation powder.
- subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening
- subjects are medically unable to withhold albuterol or ipratropium for 4 hours prior to spirometry testing at each study visit
- subjects are medically unable to stop the 'excluded medications' listed in the protocol
- subjects started, discontinued certain medications listed in the protocol or have not been on a stable dose in the past three months prior to Screening, or are not anticipated to remain on a stable dose during the study treatment period.
- Long term oxygen therapy requiring >12 hour per day or a flow rate > 2 L/min
- A body mass index = or >35 kg/m2
- Fasting lipid level LDL>3.3 mmol/L, total cholesterol >5.2 mmol/L, and triglycerides > 2.24mmol/L
- Non-compliance
- Questionable validity of consent
- Prior use of study medication or other investigational drugs.
- Affiliation with investigator site
Trial location(s)
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32825
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32608
Status
Study Complete
Location
GSK Investigational Site
Muncie, Indiana, United States, 47304-5547
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
2014-04-11
Actual study completion date
2014-04-11
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
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