Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

Almirall

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Genuair® (Almirall S.A.); Device: HandiHaler® (Boehringer Ingelheim's)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01385696

M/34273/32

Details and patient eligibility

About

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Enrollment: 130 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female patients aged ≥ 40 with stable COPD
• Naïve patients to the use of study inhalers
• Patients agreeing on participating and signing the Informed Consent Form

Exclusion criteria

• Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
• Patients unable to read product package instructions and answer patient reported questionnaires

Trial design

130 participants in 2 patient groups

group A

Experimental group

Description:

Genuair first, HandiHaler second

Treatment:

Device: HandiHaler® (Boehringer Ingelheim's)

Device: Genuair® (Almirall S.A.)

group B

Experimental group

Description:

HandiHaler first, Genuair second

Treatment:

Device: HandiHaler® (Boehringer Ingelheim's)

Device: Genuair® (Almirall S.A.)