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

This study has been terminated.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00331292

Purpose

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.

Condition
Asthma

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Study to Identify a Transcriptomic Profile Indicative of Cycle AMP Pathway Activation in the Lung

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	30
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331292

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CRB100706
Study First Received:	May 26, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00331292
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Asthma bronchoscopy

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 15, 2009