Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410877
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : June 5, 2013
Information provided by (Responsible Party):
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.

Condition or disease

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Cross-Sectional
Official Title: Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Inhaler naive healthy volunteers

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Greater Richmond Area, Virginia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410877

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

Responsible Party: Virginia Commonwealth University Identifier: NCT01410877     History of Changes
Other Study ID Numbers: HM13708
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013