Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Placebo ELLIPTA inhaler Correct use COPD Ease of use
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 278
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Subjects will be provided the ELLIPTA inhaler, which is a molded plastic two-sided inhaler that holds two individual blister strips containing either lactose or a blend of lactose and magnesium stearate. Subjects will continue to use regular COPD medications throughout the study as per protocol.

Interventions: intervention 1: Placebo intervention 2: Questionnaire
Intervention descriptions: intervention 1: Subjects will receive 1 inhalation once-daily until visit 2. intervention 2: ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2.

Protocol document: