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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Anne M Fitzpatrick PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00590005
First received: December 27, 2007
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Exhaled Nitric Oxide at Baseline and Over the Observational Period [ Time Frame: baseline and after 21 days ] [ Designated as safety issue: No ]
    Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag


Secondary Outcome Measures:
  • Reduction in Breath pH [ Time Frame: baseline and 21 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 225
Study Start Date: January 2003
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590005

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

No publications provided

Responsible Party: Anne M Fitzpatrick PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00590005     History of Changes
Other Study ID Numbers: IRB00024906, 2 R01 HL069170-07
Study First Received: December 27, 2007
Results First Received: July 10, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 14, 2014