Exhaled Nitric Oxide and Airway Caliber in Children With Asthma

NCT ID: NCT01645397

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to assess if in steroid naïve asthmatic children with elevated baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled nitric oxide level results in restoration of the bronchodilator response to deep inhalation.

Detailed Description

Previous studies have shown that a deep inhalation (DI) would increase airway caliber in normal subjects. Whereas in asthmatics with spontaneous bronchoconstriction (obstruction of the airway), DI was shown to worsen airway obstruction. The mechanism for this variability in response to DI is not well-understood, but seems to be a key in understanding the pathophysiology of the disease, and possibly in the development of an effective therapy. Air way inflammation resulting in airway wall thickening and peribronchial edema is thought to play a role how the airway responds to deep inhalation. This study assess if reduction in airway inflammation (as measured by level of exhaled NO)results in optimization of the bronchodilator response to deep inhalation

Conditions

Asthma in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Asthma, elevated exhaled NO

Children with asthma with elevated exhaled NO at initial evaluation (\>25ppb)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age: > 6 years at age of screening.
• Physician diagnosed asthma
• Elevated exhaled NO at initial evaluation (>25ppb)
• Be able to reproducibly perform DI maneuvers and all other pulmonary function testing
• Be clinically stable for at least 2 weeks prior to screening with no evidence of acute upper or lower respiratory infection or current pulmonary exacerbation.
• Has not been on inhaled or oral steroid for at least 4 weeks prior to enrollment in the study.
• Parent/child willingness to enroll in the study and provide written informed consent.
• Be able to present for the required study visits.

Exclusion Criteria

• Chest wall or spinal column deformity; known cardiac, neuromuscular, or other chronic diseases
• Use of beta agonist, theophylline, leukotriene receptor antagonists, or caffeine-containing soft drinks 12 hr prior to the study.
• Use of inhaled steroid in the past 4 weeks.
• Respiratory infection or asthma exacerbation in the previous 2 weeks

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

Patricia Breitwieser

Coordiantor, Respiratory Center for Children

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dagnachew Assefa, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

Goryeb Children's Hospital, Atlantic Health

Morristown, New Jersey, United States

Countries

United States

Other Identifiers

R10-06-013

Identifier Type: -

Identifier Source: org_study_id