Redox Determinants in Severe Asthma (SARP)
Recruitment status was Recruiting
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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 | Intervention |
|---|---|
|
Asthma |
Drug: triamcinolone Drug: albuterol Drug: methacholine PC20 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Redox Determinants in Severe Asthma |
- improvemewnt in post-bronchodilator FEV1 (cut point 15% [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Reduction in exhaled NO (cut point 25%) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Increasze in breath pH (cut point 10%) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
-
Drug: triamcinolone
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 |
Inclusion Criteria:
- At least 6 years old
- Asthma diagnosis by physician
- Current treatment with an inhaled corticosteroid medication
Contacts and Locations| United States, Georgia | |
| Emory Childrens Center | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Eric Hunter, BS 404-727-3691 eric_hunter@oz.ped.emory.edu | |
| Principal Investigator: William G Teague, MD | |
More Information
No publications provided
| Responsible Party: | W. Gerald Teague, MD, Emory University |
| ClinicalTrials.gov Identifier: | NCT00590005 History of Changes |
| Other Study ID Numbers: | 2 R01 HL069170-07 |
| Study First Received: | December 27, 2007 |
| Last Updated: | January 9, 2008 |
| 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 Albuterol Methacholine Chloride Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate |
Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013