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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Age 5-6.5

Group 1 will consist of 16 children aged 5-6.5 years

Pressurized Metered-Dose Inhaler

Intervention Type DEVICE

Pressurized Metered-Dose Inhaler

Aged 6.6- 8 years

Group 2 will consist of 16 children aged 6.6- 8 years

Pressurized Metered-Dose Inhaler

Intervention Type DEVICE

Pressurized Metered-Dose Inhaler

Interventions

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Pressurized Metered-Dose Inhaler

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No