Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma
Status:
Completed
Trial end date:
2016-02-04
Target enrollment:
Participant gender:
Summary
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.