Changes in the Lung Clearance Index in Pediatric Patients With Asthma

NCT02678949 | Unknown DMC

• 1 other identifier: HIMFG1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effect of bronchodilator on the Lung Clearance Index between children with mild or moderate asthma

  In all patients with asthma a multiple-breath washout (MBW) and standard spirometry will be perform before and after one dose of inhaled albuterol (400 mcg metered dose inhaler) delivered via standard spacer, in order to obtain forced expiratory volumen in 1 second (liters and percent of predicted value), functional residual capacity (FRC; liters and percent of predicted value) and Lung Clearance Index = cumulative expired volume/FRC.

  20 minutes

Secondary Outcomes (3)

• Change in the Lung Clearance Index after 4 weeks of treatment with inhaled fluticasone in children with mild asthma

  4 weeks

• Change in the Lung Clearance Index after 4 weeks of treatment with inhaled fluticasone in children with moderate asthma

  4 weeks

• Compare measures in the Lung Clearance Index betwwen children with and without asthma

  60 minutes

Study Arms (3)

Inhaled Fluticasone 50 mcg/twice day

EXPERIMENTAL

Group 2; Inhaled fluticasone. 50 mcg/twice day for a period of 4 weeks.

Drug: Inhaled Fluticasone 50 mcg/twice day

Inhaled Fluticasone 100 mcg/twice day

EXPERIMENTAL

Group 3;Inhaled fluticasone. 100 mcg/twice day for a period of 4 weeks

Drug: Inhaled Fluticasone 100 mcg/twice day

Inhaled Albuterol

EXPERIMENTAL

Group 2 and group 3, inhaled albuterol one dose of 400 mcg.

Drug: Inhaled Albuterol

Interventions

Inhaled Fluticasone 50 mcg/twice day DRUG

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.

Also known as: Fluticasone

Inhaled Fluticasone 50 mcg/twice day

Inhaled Fluticasone 100 mcg/twice day DRUG

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.

Also known as: Fluticasone

Inhaled Fluticasone 100 mcg/twice day

Inhaled Albuterol DRUG

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.

Also known as: Albuterol

Inhaled Albuterol

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed written consent signed by a parent or guardian of the patient and by the patient (asthma and healthy controls).
• Diagnosis of mild asthma and moderate asthma according to the criteria of the Global Initiative for Asthma 2014 (Global Strategy for Asthma Management and Prevention. National Institutes of Health 2014), treated with inhaled steroids and who come to the outpatient Clinic of Pediatric Pulmonology at Hospital Infantil de Mexico.
• An evolution of the asthma \> 6 months.
• Able to perform spirometry test and multiple-breath washout test.
• No exacerbation of asthma in the past 4 weeks.
• Accept a washout period (without treatment) for 1 week before the realization of studies of pulmonary function.
• Accept the use of necessary short-acting B2 bronchodilator during the washout period.
• Do not suffer from any other chronic disease other than asthma.

You may not qualify if:

• Patient with acute or chronic pulmonary disease other than asthma.
• Patients with a diagnosis of severe asthma.
• Other co-morbidities.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico City, 06020, Mexico

Location

Related Publications (16)

• Downie SR, Salome CM, Verbanck S, Thompson B, Berend N, King GG. Ventilation heterogeneity is a major determinant of airway hyperresponsiveness in asthma, independent of airway inflammation. Thorax. 2007 Aug;62(8):684-9. doi: 10.1136/thx.2006.069682. Epub 2007 Feb 20.

  PMID: 17311839 BACKGROUND

• Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002 Feb;109(2 Suppl):S447-60. doi: 10.1067/mai.2002.121409.

  PMID: 11842317 BACKGROUND

• Tulic MK, Christodoulopoulos P, Hamid Q. Small airway inflammation in asthma. Respir Res. 2001;2(6):333-9. doi: 10.1186/rr83. Epub 2001 Aug 10.

  PMID: 11737932 BACKGROUND

• Enright PL, Lebowitz MD, Cockroft DW. Physiologic measures: pulmonary function tests. Asthma outcome. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 2):S9-18; discussion S19-20. doi: 10.1164/ajrccm/149.2_Pt_2.S9.

  PMID: 8298772 BACKGROUND

• Ruppel GL, Enright PL. Pulmonary function testing. Respir Care. 2012 Jan;57(1):165-75. doi: 10.4187/respcare.01640.

  PMID: 22222135 BACKGROUND

• Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.

  PMID: 16264058 BACKGROUND

• Verbanck S, Schuermans D, Van Muylem A, Melot C, Noppen M, Vincken W, Paiva M. Conductive and acinar lung-zone contributions to ventilation inhomogeneity in COPD. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1573-7. doi: 10.1164/ajrccm.157.5.9710042.

  PMID: 9603140 BACKGROUND

• Tashkin DP. The role of small airway inflammation in asthma. Allergy Asthma Proc. 2002 Jul-Aug;23(4):233-42.

  PMID: 12221892 BACKGROUND

• Timmins SC, Diba C, Farrow CE, Schoeffel RE, Berend N, Salome CM, King GG. The relationship between airflow obstruction, emphysema extent, and small airways function in COPD. Chest. 2012 Aug;142(2):312-319. doi: 10.1378/chest.11-2169.

  PMID: 22345381 BACKGROUND

• Verbanck S, Schuermans D, Paiva M, Vincken W. The functional benefit of anti-inflammatory aerosols in the lung periphery. J Allergy Clin Immunol. 2006 Aug;118(2):340-6. doi: 10.1016/j.jaci.2006.04.056. Epub 2006 Jun 21.

  PMID: 16890756 BACKGROUND

• Verbanck S, Thompson BR, Schuermans D, Kalsi H, Biddiscombe M, Stuart-Andrews C, Hanon S, Van Muylem A, Paiva M, Vincken W, Usmani O. Ventilation heterogeneity in the acinar and conductive zones of the normal ageing lung. Thorax. 2012 Sep;67(9):789-95. doi: 10.1136/thoraxjnl-2011-201484. Epub 2012 Apr 27.

  PMID: 22544894 BACKGROUND

• Macleod KA, Horsley AR, Bell NJ, Greening AP, Innes JA, Cunningham S. Ventilation heterogeneity in children with well controlled asthma with normal spirometry indicates residual airways disease. Thorax. 2009 Jan;64(1):33-7. doi: 10.1136/thx.2007.095018. Epub 2008 Aug 4.

  PMID: 18678703 BACKGROUND

• Verbanck S, Schuermans D, Paiva M, Vincken W. Nonreversible conductive airway ventilation heterogeneity in mild asthma. J Appl Physiol (1985). 2003 Apr;94(4):1380-6. doi: 10.1152/japplphysiol.00588.2002. Epub 2002 Dec 6.

  PMID: 12471044 BACKGROUND

• Verbanck S, Schuermans D, Vincken W. Inflammation and airway function in the lung periphery of patients with stable asthma. J Allergy Clin Immunol. 2010 Mar;125(3):611-6. doi: 10.1016/j.jaci.2009.10.053. Epub 2010 Feb 4.

  PMID: 20132975 BACKGROUND

• Horsley A. Lung clearance index in the assessment of airways disease. Respir Med. 2009 Jun;103(6):793-9. doi: 10.1016/j.rmed.2009.01.025. Epub 2009 Feb 25.

  PMID: 19246184 BACKGROUND

• Singer F, Abbas C, Yammine S, Casaulta C, Frey U, Latzin P. Abnormal small airways function in children with mild asthma. Chest. 2014 Mar 1;145(3):492-499. doi: 10.1378/chest.13-0784.

  PMID: 24091465 BACKGROUND

MeSH Terms

Interventions

Fluticasone; Albuterol

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Jose L Lezana, MD

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose L Lezana, MD

CONTACT

55 52289917; lezana_doc@yahoo.com.mx

Jose J Leija, MD

CONTACT

55 52289917; leijamjj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Pulmonologist

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 10, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)