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

• ClinicalTrials.gov Identifier: NCT00590005
• Recruitment Status: Completed
• First Posted: January 10, 2008
• Results First Posted: January 13, 2014
• Last Update Posted: February 10, 2014
• Sponsor: Emory University
• Collaborator: The Cleveland Clinic
• Information provided by (Responsible Party): Anne M Fitzpatrick PhD, Emory University

Study Description

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

Condition or disease
Asthma

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 225 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program
• Study Start Date: January 2003
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Exhaled Nitric Oxide at Baseline and Over the Observational Period [ Time Frame: baseline and after 21 days ]
   Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag

Secondary Outcome Measures :

1. Reduction in Breath pH [ Time Frame: baseline and 21 days ]
   Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children with physician-diagnosed asthma in the Atlanta, Georgia area across a wide range of asthma severities (mild, moderate, severe)

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

Contacts and Locations

Locations

United States, Georgia

Emory Childrens Center

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

The Cleveland Clinic

Investigators

• Principal Investigator: W G Teague, MD; University of Virginia

More Information

• Responsible Party: Anne M Fitzpatrick PhD, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT00590005
• Other Study ID Numbers: IRB00024906; 2R01HL069170-07 ( U.S. NIH Grant/Contract )
• First Posted: January 10, 2008
• Results First Posted: January 13, 2014
• Last Update Posted: February 10, 2014
• Last Verified: January 2014

Keywords provided by Anne M Fitzpatrick PhD, Emory University:

severe asthma; poorly controlled asthma

Additional relevant MeSH terms:

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