Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics

NCT00615706 | Completed

• 2 other identifiers: 345-2004Emory IRB ID 345-2004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

asthma, inhaled corticosteroids

Study Arms (2)

1

Asthmatics

Other: No intervention

2

Healthy volunteers (without asthma)

Other: No intervention

Interventions

No intervention OTHER

no intervention

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthmatics and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Critical Therapeutics: collaborator

Study Sites (1)

Emory University, Emory Crawford Long Hospital, Clinical Research Center

Atlanta, Georgia, 30308, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 14, 2008
• Study Start: January 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 23, 2008

Record last verified: 2008-09

Locations

US (1)