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An Open-label Study of the Ease of Use and Correct Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Asthma
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2. ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Aventura, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Sunset, Louisiana, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
North Dartmouth, Massachusetts, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Plymouth, Minnesota, United States
GSK Investigational Site
Charlotte, North Carolina, United States
Start Date
October 1, 2015
Primary Completion Date
February 4, 2016
Completion Date
February 4, 2016
Last Updated
October 11, 2017
259
ACTUAL participants
Placebo ELLIPTA inhaler
DRUG
Questionnaire
OTHER
Lead Sponsor
GlaxoSmithKline
NCT07219173
NCT07486401
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02327897