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

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ClinicalTrials.gov Identifier: NCT01714063
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma Device: Pressurized Metered-Dose Inhaler

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
Study Start Date : December 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.



Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 subjects aged 5-8 diagnosed with asthma
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714063


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Philips Respironics
Investigators
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Principal Investigator: Ariel Berlinski, MD University of Arkansas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01714063    
Other Study ID Numbers: RDD-2010-001
First Posted: October 25, 2012    Key Record Dates
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Philips Respironics:
pediatric
asthma
metered dose inhaler
valved holding chamber
pMDI
VHC
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases