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A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This study is currently recruiting participants.
Verified by GlaxoSmithKline, August 2009
First Received: March 5, 2009   Last Updated: August 13, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00857766
  Purpose

The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.


Condition Intervention
Cardiovascular Disease
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD)
CV Risk
Emphysema
Smoking
Drug: ADVAIR DISKUS™ 250/50mcg
Other: Placebo

Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS™ 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary outcome measure is Pulse Wave Velocity. [ Time Frame: The time frame is 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measures are Augmentation Index (AIx) and Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: The time frame is 5 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

DNA derived from blood will be stored


Estimated Enrollment: 250
Study Start Date: March 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Placebo
Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Other: Placebo
COPD subjects-Placebo DISKUS
ADVAIR DISKUS
Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Drug: ADVAIR DISKUS™ 250/50mcg
ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Detailed Description:

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC) BID on arterial stiffness in COPD subjects. Following a 1 to 14 day run-in period, approximately 250 subjects will be randomly assigned to double-blind treatment for 12 weeks. After the 12 week treatment period, subjects in both treatment arms will receive open label Tiotropium bromide Handihaler18mcg (Tio)QD for 4 weeks in addition to their continued study drug (either FSC250/50 or placebo). The primary measure of efficacy is Pulse Wave Velocity (PWV) at Endpoint. Secondary efficacy measures include Augmentation Index (AIx), Biomarkers of cardiovascular disease, measures of lung function. (e.g. FEV1). Safety will be assessed through the collection of adverse events and COPD exacerbations. Exploratory endpoints include the effect of Tiotropium on PWV and AIx when added to placebo or FSC. Treatment groups will be stratified based on current smoking status. There will be a total of 6 study visits (screening, randomization, and after 4, 8, 12 and 16 weeks of treatment). A follow-up phone contact for collection of adverse event and pregnancy information (if applicable) will be conducted approximately 14 days following the last study visit.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with COPD who have at least a 10 pack year smoking history and obstruction as defined by pulmonary function test.

Criteria

Inclusion Criteria:

  • Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
  • Males or females greater then or equal to 50 years of age.
  • A post-albuterol FEV1/FVC ratio of < or equal to 0.70
  • A post-albuterol FEV1 < 80% of predicted normal.
  • Patients can be current or fomer smoker and must have a cigarette smoking history of > greater then or equal to 10 pack-years .

Exclusion Criteria:

  • A current diagnosis of asthma
  • A body mass index (BMI) of > or equal to 35kg/m2
  • A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857766

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 25 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 112355
Study First Received: March 5, 2009
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00857766     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
pulse wave velocity
arterial stiffness
Chronic Obstructive Pulmonary Disease
Computed Tomography
Pulse wave analysis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Pulmonary Emphysema
Lung Diseases, Obstructive
Pathologic Processes
Tocolytic Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Cardiovascular Diseases
Bronchitis
Dermatologic Agents
Emphysema
Salmeterol
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Bronchitis, Chronic
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010