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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590005
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : January 13, 2014
Last Update Posted : February 10, 2014
The Cleveland Clinic
Information provided by (Responsible Party):
Anne M Fitzpatrick PhD, Emory University

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

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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.

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.

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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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590005

United States, Georgia
Emory Childrens Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
The Cleveland Clinic
Principal Investigator: W G Teague, MD University of Virginia

Responsible Party: Anne M Fitzpatrick PhD, Assistant Professor, Emory University Identifier: NCT00590005     History of Changes
Other Study ID Numbers: IRB00024906
2R01HL069170-07 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2008    Key Record Dates
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:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases