A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01336608
First received: March 31, 2011
Last updated: October 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Fluticasone Furoate/Vilanterol
Drug: Vilanterol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in aortic pulse wave velocity at the end of 24-week treatment period [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in clinic visit pre-dose trough FEV1 (in Liters) at the end of 24-week treatment period [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Number of occasions COPD rescue medication use during a 24-hour period average over the 24-week treatment period [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 444
Study Start Date: March 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone Furoate/Vilanterol
Inhaled corticosteroid/long acting beta-agonist
Drug: Fluticasone Furoate/Vilanterol
Inhaled corticosteroid/long acting beta-agonist
Experimental: vilanterol
Inhaled long acting beta-agonist
Drug: Vilanterol
Inhaled long acting beta-agonist
Placebo Comparator: placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01336608

  Show 72 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01336608     History of Changes
Other Study ID Numbers: 113108
Study First Received: March 31, 2011
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014