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 currently recruiting participants. (see Contacts and Locations)
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: April 21, 2014
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: June 2014
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: April 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014