Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01410877
First received: August 1, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in inhalation flow rate and inhalation volume after the formal training in use of inhaler [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Inhalation Profiles will be collected through different airflow resistance, before and after formal training


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Inhaler naive healthy volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Greater Richmond Area, Virginia

Criteria
  • Must be healthy as determined by a health questionnaire
  • Must not be currently pregnant (self reported)
  • Must not have symptoms of an obstructive or restrictive lung disease or be suffering from allergies or congestion at the time of testing
  • Must have Forced 'Expiratory Volume in one second' >'Lower Limit of Normal' predicted
  • Must be medically stable with no evidence of acute medical or psychiatric illness,
  • Must have never used or been trained to use a dry powder inhaler,
  • Must not be currently using any inhaler, nasal spray or drug known to affect lung function, Bronchodilators and decongestants in any form are excluded
  • Must be at least 4 feet 10 inch tall,
  • Must weigh at least 110 pounds (50 kilograms) and be no more than 264 pounds (120 kilograms)
  • Must not currently, or in the past year, have used tobacco products
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01410877

Locations
United States, Virginia
Virginia Commonwealth University, School of Pharmacy
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Peter R Byron, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01410877     History of Changes
Other Study ID Numbers: HM13708
Study First Received: August 1, 2011
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014