AsthmaNCT05762978
Evaluation of Negative Inspiratory Flow in Children With Acute Asthma
A study testing In-Check Dial and Inhaler Device in people with Asthma, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- In-Check Dial and Inhaler Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hospitalized with asthma
- Age ≥ 4 years and < 8 years
Who cannot join
- Acute Lung Disease
- Chronic lung disease
- Developmental Delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- In-Check Dial, Inhaler Device
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Check DialDevice
Patient will have their NIF measured with In-Check Dial
Inhaler DeviceDevice
Children will use inhaler per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic Children | Experimental | NIF will be measured using an In-Check Dial Receives: Device: In-Check Dial; Device: Inhaler Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIF (Negative Inspiratory Flow)
NIF measures a patient's maximum inspiratory effort after exhaling.
Measured: Time of Hospital Admission (Day 1)
NIF (Negative Inspiratory Flow)
NIF measures a patient's maximum inspiratory effort after exhaling.
Measured: Hospital Discharge (Typically Day 1-2)
NIF (Negative Inspiratory Flow)
NIF measures a patient's maximum inspiratory effort after exhaling.
Measured: Follow-Up Visits (Week 2 Post-Discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study startDec 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Halaby, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762978
- Sponsor's protocol ID
- 15035
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2016
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05762978
- Acronym / sponsor ID
- 15035
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatic Children | Experimental | Device: In-Check Dial, Device: Inhaler DeviceNIF will be measured using an In-Check Dial |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Hospitalized with asthma
- Age ≥ 4 years and < 8 years
Key exclusion criteria (3 listed)
- Acute Lung Disease
- Chronic lung disease
- Developmental Delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Check DialPatient will have their NIF measured with In-Check Dial | Device | Asthmatic Children |
| Inhaler DeviceChildren will use inhaler per standard of care. | Device | Asthmatic Children |
Primary outcome
NIF (Negative Inspiratory Flow)
Time frame: Time of Hospital Admission (Day 1)
NIF measures a patient's maximum inspiratory effort after exhaling.
NIF (Negative Inspiratory Flow)
Time frame: Hospital Discharge (Typically Day 1-2)
NIF measures a patient's maximum inspiratory effort after exhaling.
NIF (Negative Inspiratory Flow)
Time frame: Follow-Up Visits (Week 2 Post-Discharge)
NIF measures a patient's maximum inspiratory effort after exhaling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Halaby, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Check Dial and Inhaler Device in people with Asthma, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIF (Negative Inspiratory Flow) (time frame: Time of Hospital Admission (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.