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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116402
Recruitment Status : Completed
First Posted : June 29, 2005
Last Update Posted : August 5, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE June 28, 2005
First Posted Date  ICMJE June 29, 2005
Last Update Posted Date August 5, 2014
Study Start Date  ICMJE January 2005
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2005)
To evaluate blood and airway neutrophil population in COPD patients by examining adhesion and migration in patients with mild to moderate COPD
Change History Complete list of historical versions of study NCT00116402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations
Official Title  ICMJE A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Brief Summary The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: 1
    will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
    Intervention: Drug: fluticasone and salmeterol
  • Active Comparator: 2
    salmeterol 50 mcg BID then crossover to combination therapy with fluticasone 220 mcg BID
    Intervention: Drug: fluticasone and salmeterol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2009)
15
Original Enrollment  ICMJE
 (submitted: June 28, 2005)
14
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00116402
Other Study ID Numbers  ICMJE 13426B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Imre Noth, M.D. University of Chicago
PRS Account University of Chicago
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP