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

NCT ID: NCT01385696

Last Updated: 2015-06-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

Brief Summary

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Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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group A

Genuair first, HandiHaler second

Group Type EXPERIMENTAL

Genuair® (Almirall S.A.)

Intervention Type DEVICE

Inhaler with only placebo, once daily, 14 days

HandiHaler® (Boehringer Ingelheim's)

Intervention Type DEVICE

Inhaler with only placebo, once daily, 14 days

group B

HandiHaler first, Genuair second

Group Type EXPERIMENTAL

Genuair® (Almirall S.A.)

Intervention Type DEVICE

Inhaler with only placebo, once daily, 14 days

HandiHaler® (Boehringer Ingelheim's)

Intervention Type DEVICE

Inhaler with only placebo, once daily, 14 days

Interventions

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Genuair® (Almirall S.A.)

Inhaler with only placebo, once daily, 14 days

Intervention Type DEVICE

HandiHaler® (Boehringer Ingelheim's)

Inhaler with only placebo, once daily, 14 days

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordi Estruch, Head of GMA

Role: STUDY_DIRECTOR

Almirall, S.A.

Locations

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Almirall investigative site 3

Bonn, , Germany

Site Status

Almirall investigative site 5

Koblenz, , Germany

Site Status

Almirall investigative site 1

Enschede, , Netherlands

Site Status

Almirall investigative site 2

Zutphen, , Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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M/34273/32

Identifier Type: -

Identifier Source: org_study_id

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