N/A
N=34
Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01714063 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Delivered Dose of Fluticasone (on the Filter) — 48; 45; 41; 40 Percent filter dose of fluticasone — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pressurized Metered-Dose Inhaler (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivered Dose of Fluticasone (on the Filter) |
48; 45; 41; 40 | <0.001 sig |
| PRIMARY Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers |
46; 41 | — |
| SECONDARY Inspiratory Peak Flow |
25.2; 22.8; 23.3; 22; 23.2; 22.5 | — |
| SECONDARY Inspiratory Tidal Volume |
286; 269; 281; 259; 302; 266 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01714063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.