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NCT01410877 · ClinicalTrials.gov registry record
Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers
A clinical trial, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- 20
- Enrollment target
NCT01410877: Completed study, sponsored by Virginia Commonwealth University.
NCT01410877 is a clinical trial that has completed, run by Virginia Commonwealth University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410877 has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
It is hypothesized that different inhalation profiles (inhalation flow rate versus time curves) result from different forms of patient training. Furthermore, significant inter-subject variability in these profiles should exist that can, under some circumstances, depend on the design of different inhalation devices; this is because dry powder inhalers have different airflow resistances. The investigators also hypothesize that the spread of flow rate versus time profiles for inhalation can be collected. Finally, these profiles can be analyzed from a group of human subjects and used to define a mean and statistical range of inhalation flow rate versus time curves. The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy volunteers after they have (a) read a typical inhaler package insert and (b) been formally trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used from this pilot study to (a) show the inter-subject variability in the inhalation profiles used by adults inhaling through realistic airflow resistances (like those in inhalers) following different types of training (b) show how formal training changes inhalation technique and (c) provide a database of typical inspiratory profiles for use and improvement of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers greatly depends upon the way patients inhale through them, this research will result in a database to improve the design and in vitro characterization of inhalers.
Primary Outcome
Inhalation Profiles will be collected through different airflow resistance, before and after formal training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-09 |
What the finished NCT01410877 record still lists
NCT01410877 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01410877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01410877 about?
NCT01410877 is a clinical study titled "Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers". It is hypothesized that different inhalation profiles (inhalation flow rate versus time curves) result from different forms of patient training. Furthermore, significant inter-subject variability in these profiles should exist that can, under some circumstances, depend on the design of different inh...
What is the current status of trial NCT01410877?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2011-08. Estimated completion is 2011-09.
Who is sponsoring clinical trial NCT01410877?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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