Evaluation of Negative Inspiratory Flow in Children With Acute Asthma

NCT05762978 | Completed

• 1 other identifier: 15035
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

There are different inhalers used for the treatment of asthma and they work differently and require different technique for the optimal drug delivery to the lungs. One of the inhalers is the Dry Powder Inhaler (DPI). The minimal amount of Negative Inspiratory Flow (NIF) required to use this medication is 30ml/min. Studies have shown that children find it difficult to generate this NIF and studies have also shown that children generate lesser NIF during an Asthma exacerbation. The investigators will measure the NIF using an InCheck Dial on children with asthma during an exacerbation and when they are seen in clinic for a hospital follow up visit. This will be done on asthmatic children regardless of the inhaler that they use. The investigator hypothesize that children with asthma age 4-8 years cannot generate the required NIF during an Asthma exacerbation hence proving that a DPI cannot be prescribed to children at this age. This study will examine this hypothesis.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• NIF (Negative Inspiratory Flow)

  NIF measures a patient's maximum inspiratory effort after exhaling.

  Time of Hospital Admission (Day 1)

• NIF (Negative Inspiratory Flow)

  NIF measures a patient's maximum inspiratory effort after exhaling.

  Hospital Discharge (Typically Day 1-2)

• NIF (Negative Inspiratory Flow)

  NIF measures a patient's maximum inspiratory effort after exhaling.

  Follow-Up Visits (Week 2 Post-Discharge)

Study Arms (1)

Asthmatic Children

EXPERIMENTAL

NIF will be measured using an In-Check Dial

Device: In-Check Dial; Device: Inhaler Device

Interventions

In-Check Dial DEVICE

Patient will have their NIF measured with In-Check Dial

Asthmatic Children

Inhaler Device DEVICE

Children will use inhaler per standard of care.

Asthmatic Children

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalized with asthma
• Age ≥ 4 years and \< 8 years

You may not qualify if:

• Acute Lung Disease
• Chronic lung disease
• Developmental Delay

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Claudia Halaby, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: March 10, 2023
• Study Start: December 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 10, 2023

Record last verified: 2023-02

Locations

US (1)