Clinical trial NCT02786927
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: HANDIHALER Dry Powder Inhaler COPD ELLIPTA Inhaler preference attributes
Sponsor: GlaxoSmithKline
Start date: 2016-06-21; Completion date: 2016-10-04
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication.

All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period.

This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study.

Approximately 211 subjects will be enrolled in the study.

ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.

Detailed description:

Arms: arm 1: Subjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire. arm 2: Subjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire. arm 3: Subjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire. arm 4: Subjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire.
Interventions: intervention 1: Placebo ELLIPTA device intervention 2: Placebo capsules for use in HANDIHALER device intervention 3: Inhaler Preference Questionnaire Version 1 intervention 4: Inhaler Preference Questionnaire Version 2
Intervention descriptions: intervention 1: Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate. intervention 2: Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days. intervention 3: Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses. intervention 4: Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.

Protocol documents: