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

This study is not yet open for participant recruitment.
Verified November 2012 by Philips Respironics
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01714063
First received: October 18, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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
Asthma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Delivered dose of fluticasone (on the filter) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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:
  • Inspiratory peak flow [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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

  • Inspiratory tidal volume [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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:
  • Measurement residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714063

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

Locations
United States, Arkansas
Arkansas Children's Hospital Not yet 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

No publications provided

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01714063     History of Changes
Other Study ID Numbers: RDD-2010-001
Study First Received: October 18, 2012
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014