Exhaled Nitric Oxide and Airway Caliber in Children With Asthma

Asthma in Children Clinical Trial

Official title:

Exhaled Nitric Oxide and Airway Caliber in Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645397
• Other study ID #: R10-06-013
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: January 15, 2014
• Start date: June 2011
• Est. completion date: August 2013

Study information

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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Locations

Country	Name	City	State
United States	Goryeb Children's Hospital, Atlantic Health	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Ratio of post DI to pre DI airway resistance from baseline at 4 weeks of treatment with inhaled steroid	Post-DI to pre-DI airway resistance at 5 Hz (R5) ratio (as measured by impulse oscillometry) from baseline (elevated exhaled NO) to 4-6 weeks of treatment.	at baseline and 4 weeks later	No