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

May 28, 2015 updated by: Almirall, S.A.

Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53119
        • Almirall investigative site 3
      • Koblenz, Germany, 56068
        • Almirall investigative site 5
  • Netherlands
      • Enschede, Netherlands, 7511 JX
        • Almirall investigative site 1
      • Zutphen, Netherlands, 7207 AE
        • Almirall investigative site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
Genuair first, HandiHaler second
Device: Genuair® (Almirall S.A.)
Inhaler with only placebo, once daily, 14 days
Device: HandiHaler® (Boehringer Ingelheim's)
Inhaler with only placebo, once daily, 14 days
Experimental: group B
HandiHaler first, Genuair second
Device: Genuair® (Almirall S.A.)
Inhaler with only placebo, once daily, 14 days
Device: HandiHaler® (Boehringer Ingelheim's)
Inhaler with only placebo, once daily, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
Time Frame: 14 days
Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Overall Satisfaction With Genuair and Handihaler at Visit 2
Time Frame: 14 days
The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)
14 days
Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2
Time Frame: 14 days

The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2).

Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almirall, S.A.

Investigators

  • Study Director: Jordi Estruch, Head of GMA, Almirall, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

June 29, 2011

First Posted (Estimate)

June 30, 2011

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M/34273/32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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