Effect of an Inhaled Glucocorticoid-long-acting Beta Adrenergic Agonist on Endothelial Function in COPD

NCT01209715 | Withdrawn Phase 2

• 1 other identifier: 114279
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study, the investigators wish to address the effect of a glucocorticoid/long-acting beta-agonist preparation on endothelial function in COPD patients who do not currently smoke (ex-smokers) by measuring endothelium-dependent (albuterol response) and endothelium-independent (NTG response) vasodilation in the bronchial artery, reflecting endothelium-dependent and endothelium-independent vasodilation (drug-induced increase in Qaw, ΔQaw). With this approach the investigators will test the hypothesis that in stable ICS-naïve COPD patients, endothelium-dependent vasodilation is restored with a glucocorticoid/long-acting beta-agonist preparation, presumably resulting from the glucocorticoid component.

Conditions

COPD

Keywords

airway blood flow,; COPD,; endothelial dysfunction; inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

• long term effect of a glucocorticoid/long-acting beta-agonist on endothelial function in the bronchial artery.

  To determine the effect of a medium dose glucocorticoid/long-acting beta-agonist preparation (250 μg fluticasone plus 50 μg salmeterol) or placebo administered for 3 weeks on inhaled albuterol and sub-lingual NTG induced vasodilation in the bronchial artery, as assessed by ΔQaw in stable glucocorticoid-naïve COPD patients, and to re-assess the responses after a 3 week washout period.

  3 weeks

Secondary Outcomes (1)

• acute effect of an ICS on bronchial endothelial function in stable glucocorticoid-naïve COPD patient.

  30 minutes and 120 minutes after inhaled albuterol and sub-lingual NTG

Study Arms (2)

Matching Placebo

PLACEBO COMPARATOR

Participants will be treated with placebo twice a day for 3 weeks.

Drug: Placebo; Drug: Fluticasone /salmeterol

Fluticasone/salmeterol

ACTIVE COMPARATOR

Participants will be assigned to inhaled fluticasone/salmeterol twice a day for 3 weeks.

Drug: Fluticasone /salmeterol

Interventions

Placebo DRUG

participants will be assigned to 3-weeks treatment of inhaled placebo twice a day

Matching Placebo

Fluticasone /salmeterol DRUG

Participant will be assigned to a 3-weeks treatment with inhaled fluticasone/salmeterol or matching placebo

Also known as: Advair 250/50

Fluticasone/salmeterol; Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking history of at least 10 pack-years and to have quit smoking at least 1 year before the study. -Diagnosis of COPD
• Post-bronchodilator FEV1 of less than 75% of predicted and FEV1/FVC ratio less than 0.7 (GOLD stage ≥2).
• At entry into the study, the subjects will have to be clinically stable; they will be allowed to use short-acting and long-acting β2 - adrenergic agonists and cholinergic antagonists as their usual airway medication.

You may not qualify if:

• Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women.
• Use of cardiovascular medications that cannot be held on the study days
• Use of oral airway medications or anti-inflammatory agents
• Subjects with known beta-adrenergic agonist or NTG intolerance
• Acute respiratory infection within four weeks prior to the study
• A body mass index \> 30

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

US (1)