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Clinical Trials/NCT01410877
NCT01410877
Completed
Not Applicable

Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

Virginia Commonwealth University1 site in 1 country20 target enrollmentAugust 2011
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Virginia Commonwealth University
Enrollment
20
Locations
1
Primary Endpoint
Change in inhalation flow rate and inhalation volume after the formal training in use of inhaler
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
September 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in inhalation flow rate and inhalation volume after the formal training in use of inhaler

Time Frame: 1 year

Inhalation Profiles will be collected through different airflow resistance, before and after formal training

Study Sites (1)

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