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

Philips

Status: Completed

Conditions: Asthma

Treatments: Device: Pressurized Metered-Dose Inhaler

Study type: Observational

Funder types: Industry

Identifiers

NCT01714063

RDD-2010-001

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

34 participants in 2 patient groups

Age 5-6.5

Description:

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

Treatment:

Device: Pressurized Metered-Dose Inhaler

Aged 6.6- 8 years

Description:

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

Treatment:

Device: Pressurized Metered-Dose Inhaler