Exhaled Nitric Oxide and Airway Caliber in Children With Asthma

NCT01645397 | Completed

• 1 other identifier: R10-06-013
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

Asthma; Deep inhalation; Exhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

• Change in M/P40 ratio from baseline at 4 weeks of treatment with inhaled steroid

  M/P40 ratio is defined as the ratio of flow at 40% of FVC (forced vital capacity) on the flow-volume curve after maximal inspiration to flow at 40% of FVC on the flow-volume curve after partial (60%-70% of FVC) inspiration (M/P40 ratio)

  at baseline and 4 weeks later

Secondary Outcomes (1)

• Change in Ratio of post DI to pre DI airway resistance from baseline at 4 weeks of treatment with inhaled steroid

  at baseline and 4 weeks later

Study Arms (1)

Asthma, elevated exhaled NO

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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children, six years of age or older, with asthma attending asthma clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Goryeb Children's Hospital, Atlantic Health

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Dagnachew Assefa, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordiantor, Respiratory Center for Children

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: July 20, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

US (1)