Impedance Pneumography in Assessment of Asthma Control in Preschool Children

NCT03377192 | Unknown DMC

• 1 other identifier: VCS-002
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children

Conditions

Wheezing; Asthma in Children

Keywords

Impedance pneumography; Respiratory function; Asthma management

Outcome Measures

Primary Outcomes (1)

• Childhood asthma control test (C-ACT)

  Questionnaire that measures current asthma control, including 7 questions and a minimum score of 0 and maximum score of 27; score 19 or less indicates that asthma is not controlled.

  Weekly up to maximum 6 months or until loss of asthma control/exacerbation

Secondary Outcomes (3)

• Time-to-response (TTR)

  Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months

• Time-to-loss-of-control (TTLOC)

  Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months

• Lung function

  Every visit up to maximum 6 months

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Thirty (30) patients who have attended pediatric ward in the study centre(s) due to asthmatic symptoms (wheeze, cough, dyspnea) will be recruited.

You may qualify if:

• Age 4-7 years, both sexes
• Attending pediatric ward in the study centre due to asthmatic symptoms (wheeze, cough and/or dyspnea)
• History and clinical signs allowing diagnosis of doctor diagnosed asthma and the need to start regular anti-asthmatic medication
• Signed informed consent

You may not qualify if:

• Use of inhaled corticosteroid medication 30 days prior to study entry
• Other cardiorespiratory or neurological chronic diseases or states that may affect breathing
• Acute respiratory infection 2 weeks prior to study entry
• Chronic respiratory disorder of prematurity
• Implanted or external active medical devices

Sponsors & Collaborators

• HUS Skin and Allergy Hospital: lead
• Revenio Research: collaborator
• Mehiläinen: collaborator

Study Sites (2)

HUS Skin and Allergy Hospital

Helsinki, 00029, Finland

Location

Mehiläinen Paediatric Allergy Clinic

Helsinki, 00260, Finland

Location

Related Publications (1)

• Burman J, Malmberg LP, Remes S, Jartti T, Pelkonen AS, Makela MJ. Impulse oscillometry and free-running tests for diagnosing asthma and monitoring lung function in young children. Ann Allergy Asthma Immunol. 2021 Sep;127(3):326-333. doi: 10.1016/j.anai.2021.03.030. Epub 2021 Apr 2.

  PMID: 33819614 DERIVED

MeSH Terms

Conditions

Respiratory Sounds; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Pekka Malmberg, MD, PhD

  HUS Skin and Allergy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical physiology

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 19, 2017
• Study Start: November 28, 2017
• Primary Completion: November 14, 2019
• Study Completion: June 1, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

FI (2)