Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
An Open-label Study of the Correct Use and Ease of Use of Placebo ELLIPTA Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease
characterized by airflow limitation that is not fully reversible. The mainstay for treatment
involves the use of inhaled medications, including short and/or long-acting bronchodilators
along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device
is an important consideration because an inadequate technique reduces the effects of
inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to
the lungs effectively, is important. This study will assess the correct use of the ELLIPTA
inhaler by subjects with COPD and 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 COPD and receiving COPD 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.
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