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Changes in the Lung Clearance Index in Pediatric Patients With Asthma

NCT02678949 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2016-02-19

No results posted yet for this study

Summary

The multiple breath washout (MBW) is one of pulmonary function test that displays flow and gas concentration plotted against time, and shows an exponential decay in end-tidal gas concentration (washout curve). A number of of indices to describe the washout curve have been proposed, the most commonly reported is the Lung Clearance Index (LCI). This is a simple measure of ventilation heterogeneity derived from MBW, that can be used after challenge with a short action bronchodilator and in response to inhaled steroids, both in the conductive airways as acinar. Patients with moderate and severe asthma are characterized by an abnormality in both, conductive and the acinar airway. Therefore the following research question could be: what are the abnormalities in the heterogeneity of ventilation in children with mild and moderate asthma, with respect to the healthy population measured by MBW, and whether these alterations persist after challenge with inhaled steroids and B2 agonists short-acting.

Conditions

  • Childhood Asthma

Interventions

DRUG

Inhaled Fluticasone 50 mcg/twice day

After 7 days washout period, patients with mild asthma (group 2) will come to visit 2 where carried out a baseline spirometry and MBW test, subsequently will indicate them start treatment with inhaled fluticasone 50 mcg/twice a day, for a period of 4 weeks. At the end of the 4 weeks of treatment patients will come to Visit 3 and perform again spirometry and MBW test.

DRUG

Inhaled Fluticasone 100 mcg/twice day

After 7 days washout period, patients with moderate asthma (group 3) will come to visit 2 where carried out a baseline spirometry and MBW test, subsequently will indicate them start treatment with inhaled fluticasone of 100 mcg/twice a day, for 4 weeks period. At the end of the 4 weeks of treatment patients will come to Visit 3 and perform again spirometry and MBW test.

DRUG

Inhaled Albuterol

The patients in Group 2 and group 3 performing a baseline spirometry and MBW test, after which one dose of 400 mcg of inhaled albuterol will be administered. Twenty minutes after inhaling the dose of albuterol, spirometry and MBW test will be measured again in both groups.

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    lead OTHER

Principal Investigators

  • Jose L Lezana, MD · Hospital Infantil de Mexico Federico Gomez

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678949 on ClinicalTrials.gov