A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations

August 4, 2014 updated by: University of Chicago

A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our objective is to examine the mechanism of the additive/synergistic properties of b2-adrenoceptor stimulation and corticosteroid receptor activation in:

  • Preventing neutrophil adhesion to specific endothelial ligands, e.g. ICAM-1 and
  • Undergoing activation as a consequence of this adhesion.

We hypothesize that combination therapy with salmeterol + fluticasone (FP) will:

  • Augment the inhibition of adhesion of neutrophils obtained from the peripheral blood of study subjects in vitro, by blocking gIV-PLA2 translocation to the nuclear membrane as for eosinophils;
  • Augment the inhibition of transendothelial migration of neutrophils into airways of subjects with chronic obstructive pulmonary disease;
  • Augment the numbers and concentrations of pro-inflammatory products in the bronchoalveolar lavage fluid; and
  • Decrease the number of neutrophils in the bronchial tissue of endobronchial biopsies of treated patients.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Department of Medicine, Pulmonary & Critical Care Section, The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females > 50 years of age
  • Physiologic evidence of COPD defined per ATS guidelines as: cigarette smoking history >20 pack years, FEV1/FVC <70%
  • Patients must have a post-bronchodilator FEV1 >50% of predicted value at enrollment
  • Patient must have an O2 saturation measure by pulse oximetry >90% on RA
  • Must be able to participate in the study, willing to give informed consent, and comply with the study restrictions

Exclusion Criteria:

  • Women of child-bearing potential defined as females who are less than 5 years post menopausal unless they have had a hysterectomy or bilateral oophorectomy
  • Observation of any solitary nodule in the lung requiring further medical intervention
  • Patients on maintenance therapy with oral steroids
  • Patients with giant bullous disease
  • Significant other medical conditions, which in the opinion of the investigator, will interfere with the patient's ability to perform the study tests
  • Presence of a coagulopathy as defined by a platelet count <100,000/mm3, and PT and PTT >1.2 x the upper limit of normal
  • Concurrent enrollment or participation in any other clinical trials within the past 30 days
  • Primary diagnosis of asthma
  • History of alpha 1 antitrypsin deficiency
  • Any clinically significant and active pulmonary disease that could contribute to dyspnea
  • Current systemic and inhaled steroids and theophylline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
Drug: fluticasone and salmeterol
  1. will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
  2. will start with salmeterol 50 mcg BID first and then crossover to combination therapy with fluticasone 220 mcg BID.
Active Comparator: 2
salmeterol 50 mcg BID then crossover to combination therapy with fluticasone 220 mcg BID
Drug: fluticasone and salmeterol
  1. will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
  2. will start with salmeterol 50 mcg BID first and then crossover to combination therapy with fluticasone 220 mcg BID.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate blood and airway neutrophil population in COPD patients by examining adhesion and migration in patients with mild to moderate COPD
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Imre Noth, M.D., University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 28, 2005

First Submitted That Met QC Criteria

June 28, 2005

First Posted (Estimate)

June 29, 2005

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13426B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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