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

January 14, 2014 updated by: Anne M Fitzpatrick PhD, Emory University

Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Childrens Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and after 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

The Cleveland Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00024906
  • 2R01HL069170-07 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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