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

Asthma Clinical Trial

— SARP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590005
• Other study ID #: IRB00024906
• Secondary ID: 2 R01 HL069170-0
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: January 14, 2014
• Start date: January 2003
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Emory Childrens Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled Nitric Oxide at Baseline and Over the Observational Period	Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag	baseline and after 21 days	No
Secondary	Reduction in Breath pH	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	No