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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 : Unknown
Verified November 2012 by Philips Respironics.
Recruitment status was:  Recruiting
First Posted : October 25, 2012
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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 VHC mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.

Condition or disease
Asthma

Study Design

Study Type : Observational
Estimated Enrollment : 40 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
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Age 5-6.5
Group 1 will consist of 16 children aged 5-6.5 years
Aged 6.6- 8 years
Group 2 will consist of 16 children aged 6.6- 8 years


Outcome Measures

Primary Outcome Measures :
  1. Delivered dose of fluticasone (on the filter) [ Time Frame: Day 1 ]
    The primary objective of the present study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond VHC mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.


Secondary Outcome Measures :
  1. Inspiratory peak flow [ Time Frame: Day 1 ]
    Correlate inspiratory peak flow and inspiratory tidal volume recorded during the inhalation with amount of drug (fluticasone) deposited on filters attached to the OptiChamber Diamond VHC mouthpiece

  2. Inspiratory tidal volume [ Time Frame: Day 1 ]
    Correlate inspiratory peak flow and inspiratory tidal volume recorded during the inhalation with amount of drug (fluticasone) deposited on filters attached to the OptiChamber Diamond VHC mouthpiece


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 pMDI boot


Eligibility Criteria

Information from the National Library of Medicine

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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.
Contacts and Locations

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


Contacts
Contact: Ariel Berlinski, MD 501-364-1006 BerlinskiAriel@uams.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Ariel Berlinski, MD    501-364-1006    BerlinskiAriel@uams.edu   
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Ariel Berlinski, MD University of Arkansas
More Information

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01714063     History of Changes
Other Study ID Numbers: RDD-2010-001
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: November 2012

Keywords provided by Philips Respironics:
pediatric
asthma
metered dose inhaler
valved holding chamber
pMDI
VHC