Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)

NCT ID: NCT00590005

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2011-06-30

Brief Summary

Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways

Detailed Description

Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.

1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.

1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.

1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.

1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.

1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with severe asthma

This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000).

No interventions assigned to this group

Children with non-severe asthma

This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• At least 6 years old
• Asthma diagnosis by physician
• Current treatment with an inhaled corticosteroid medication

Exclusion Criteria

• Bronchiectasis
• Cystic Fibrosis
• Chronic Obstructive Pulmonary Disease

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Anne M Fitzpatrick PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

W G Teague, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Emory Childrens Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

2R01HL069170-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00024906

Identifier Type: -

Identifier Source: org_study_id