Evaluation of Negative Inspiratory Flow in Children With Acute Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Check Dial
Inhaler Device
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria: Hospitalized with asthma Age ≥ 4 years and < 8 years Exclusion Criteria: Acute Lung Disease Chronic lung disease Developmental Delay
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Asthmatic Children
Arm Description
NIF will be measured using an In-Check Dial
Outcomes
Primary Outcome Measures
NIF (Negative Inspiratory Flow)
NIF measures a patient's maximum inspiratory effort after exhaling.
NIF (Negative Inspiratory Flow)
NIF measures a patient's maximum inspiratory effort after exhaling.
NIF (Negative Inspiratory Flow)
NIF measures a patient's maximum inspiratory effort after exhaling.
Secondary Outcome Measures
Full Information
NCT ID
NCT05762978
First Posted
April 14, 2016
Last Updated
February 27, 2023
Sponsor
Winthrop University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05762978
Brief Title
Evaluation of Negative Inspiratory Flow in Children With Acute Asthma
Official Title
Negative Inspiratory Flow (NIF) in Children Age 4-8 Years During Acute Asthma to Evaluate the Use of a Dry Powder Inhaler: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Winthrop University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Inhaler devices are the major method for delivery of asthma medication, but their effectiveness can be compromised if the patient uses the inhaler device incorrectly. The magnitude of this problem has been well documented; in several studies less than half of the patients used their inhaler correctly. Inhaler devices are used to deliver a variety of inhaled medications, including beta-agonists, anticholinergic, and glucocorticoids. Two main types of inhaler devices are available, the pressurized metered dose inhaler (pMDI) and the dry powder inhaler (DPI).
A dry powder inhaler (DPI) is a breath-actuated device containing micronized drug particles with a mass median aerodynamic diameter (MMAD) of less than 5 µm that are usually aggregated with carrier particles (such as lactose or glucose) of greater diameter. Drug is delivered to the airways by the inhalation of air over a punctured drug-containing capsule or blister.
In this study investigators will evaluate the use of DPI use in children during an acute asthma exacerbation. The investigators hypothesize the use of DPI in children ages 4-8 during an asthma exacerbation has limited benefit, as children are unable to generate the needed NIF. The investigators will study children who were hospitalized for an acute asthma exacerbation. Additionally, the investigators will evaluate the participant as an outpatient in the pulmonary clinic / office when the participant is without an asthma exacerbation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthmatic Children
Arm Type
Experimental
Arm Description
NIF will be measured using an In-Check Dial
Intervention Type
Device
Intervention Name(s)
In-Check Dial
Intervention Description
Patient will have their NIF measured with In-Check Dial
Intervention Type
Device
Intervention Name(s)
Inhaler Device
Intervention Description
Children will use inhaler per standard of care.
Primary Outcome Measure Information:
Title
NIF (Negative Inspiratory Flow)
Description
NIF measures a patient's maximum inspiratory effort after exhaling.
Time Frame
Time of Hospital Admission (Day 1)
Title
NIF (Negative Inspiratory Flow)
Description
NIF measures a patient's maximum inspiratory effort after exhaling.
Time Frame
Hospital Discharge (Typically Day 1-2)
Title
NIF (Negative Inspiratory Flow)
Description
NIF measures a patient's maximum inspiratory effort after exhaling.
Time Frame
Follow-Up Visits (Week 2 Post-Discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hospitalized with asthma
Age ≥ 4 years and < 8 years
Exclusion Criteria:
Acute Lung Disease
Chronic lung disease
Developmental Delay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Halaby, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Negative Inspiratory Flow in Children With Acute Asthma
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