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:
Philips Respironics
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
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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 May 21, 2013