Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use

April 23, 2019 updated by: Philips Respironics
The primary objective of this study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 subjects aged 5-8 diagnosed with asthma

Description

Inclusion Criteria:

  • • Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's Hospital.

    • The subjects must be available to complete the study.
    • The subject's parent(s) and/or the subject's legal guardian must provide written informed consent to participate in the study.
    • The subject must provide assent when older than 7 years old.
    • The subjects should have used a pMDI VHC previously and be able to use a VHC with mouthpiece.
    • The subjects should have been prescribed fluticasone or another inhaled corticosteroid delivered via a pMDI VHC combination.
    • Clinically stable asthma.
    • Cooperative, i.e., subject should be able to follow and understand instructions.
    • The subject must satisfy the study investigator about his/her fitness to participate in the study.

Exclusion Criteria:

  • Clinically significant respiratory disease in the previous 4 weeks.
  • Participation in any other clinical trial in the previous 4 weeks.
  • Lack of cooperation, subject cannot follow and understand instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Age 5-6.5
Group 1 will consist of 16 children aged 5-6.5 years
Device: Pressurized Metered-Dose Inhaler
Pressurized Metered-Dose Inhaler
Aged 6.6- 8 years
Group 2 will consist of 16 children aged 6.6- 8 years
Device: Pressurized Metered-Dose Inhaler
Pressurized Metered-Dose Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivered Dose of Fluticasone (on the Filter)
Time Frame: Day 1
This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
Day 1
Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers
Time Frame: Day 1
This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory Peak Flow
Time Frame: Day 1

Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.

This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.
Day 1
Inspiratory Tidal Volume
Time Frame: Day 1

Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.

This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC
Time Frame: Day 1
Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Respironics

Investigators

  • Principal Investigator: Ariel Berlinski, MD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDD-2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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