Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

Completed

• Conditions: Healthy

• Registration Number: NCT01410877
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in inhalation flow rate and inhalation volume after the formal training in use of inhaler	1 year	Inhalation Profiles will be collected through different airflow resistance, before and after formal training

Trial Locations

Locations (1)

Virginia Commonwealth University, School of Pharmacy; 🇺🇸 Richmond, Virginia, United States