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OpenTrials
Completed

NCT Number: NCT01645397

Exhaled Nitric Oxide and Airway Caliber in Children With Asthma

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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Goryeb Children's Hospital, Atlantic Health

Morristown, New Jersey, 07960, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: at baseline and 4 weeks later

    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)

Secondary outcomes

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

    Time frame: at baseline and 4 weeks later

    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.

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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