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Completed

NCT Number: NCT00590005

Redox Determinants of Severe Asthma (a Substudy of the 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

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Key information

Conditions

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

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory Childrens Center

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • The Cleveland Clinic

Registry information

Official study title

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

Acronym: SARP

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2008
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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