Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

NCT01410877 | Completed DMC

• 1 other identifier: HM13708
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Study Arms (1)

Inhaler naive healthy volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University, School of Pharmacy

Richmond, Virginia, 23298, United States

Location

Study Officials

• Peter R Byron, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 5, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)