Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics - Full Text View

Sponsors and Collaborators:	Emory University Critical Therapeutics
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00615706

Purpose

In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways.

Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.

This research study includes optional genetic and bronchoscopy substudies.

Condition	Intervention
Asthma	Other: No intervention

MedlinePlus related topics: Asthma Obesity

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional

Further study details as provided by Emory University:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Serum, urine, DNA, exhaled breath condensate. For substudy participants, bronchoalveolar lavage samples.

Estimated Enrollment:	300
Study Start Date:	January 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Asthmatics	Other: No intervention no intervention
2 Healthy volunteers (without asthma)	Other: No intervention no intervention

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Asthmatics and healthy volunteers

Criteria

Inclusion Criteria:

Adults 18 to 70 years of age
If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid
Never smoked or limited smoking history

Exclusion Criteria:

Current upper respiratory illness (other than asthma)
Illegal drug use within past month
Consumption of more than 6 alcoholic drinks per week
Active, pronounced rhinitis or sinusitis
Pregnancy
Currently taking oral steroids or steroid injection over the past month
Asthma exacerbation over the past month
Certain medical illnesses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615706

Locations

United States, Georgia
Emory University, Emory Crawford Long Hospital, Clinical Research Center
Atlanta, Georgia, United States, 30308

Sponsors and Collaborators

Emory University

Critical Therapeutics

More Information

Responsible Party:	Emory University ( Fernando Holguin, MD, MPH )
Study ID Numbers:	345-2004, Emory IRB ID 345-2004
Study First Received:	February 4, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00615706
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

asthma, inhaled corticosteroids

Study placed in the following topic categories:

Obesity
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009