A Methodology Study To Look At Genes In Lung Cells And Tissue From Asthmatic Patients

October 15, 2008 updated by: GlaxoSmithKline

A Study to Identify a Transcriptomic Profile Indicative of Cycle AMP Pathway Activation in the Lung

The primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment

30

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Have a history of intermittant asthma.
  • Have asthma symptoms less than once per week.
  • Have no other significant disease.
  • Do not take regular oral or inhaled steroids.
  • Are a non-smoker for the past 12 months with a pack history of less than 5 years.

Exclusion criteria:

  • Have a history of drug or alcohol abuse.
  • Have poorly controlled asthma or a history of life-threatening asthma.
  • Have a history of hypersensitivity to bronchodilators.
  • Are unable to abstain from inhaled steroids from 14 days prior to the first study visit until completion of the study.
  • Have received oral steroids within 3 months of study entry.
  • Have been hospitalized for your asthma within 3 months of study entry.
  • Have had treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.

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

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

August 1, 2006

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Estimate)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 15, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRB100706

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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