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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: Genuair® (Almirall S.A.); Device: HandiHaler® (Boehringer Ingelheim's)

• Registration Number: NCT01385696
• Lead Sponsor: Almirall, S.A.

Brief Summary

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-01-14
• Results First Submitted QC: 2013-03-12
• Results First Posted: 2013-04-22
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group A	Genuair® (Almirall S.A.)	Genuair first, HandiHaler second
group B	Genuair® (Almirall S.A.)	HandiHaler first, Genuair second
group A	HandiHaler® (Boehringer Ingelheim's)	Genuair first, HandiHaler second
group B	HandiHaler® (Boehringer Ingelheim's)	HandiHaler first, Genuair second

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Overall Satisfaction With Genuair and Handihaler at Visit 2	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)
Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2	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.

Trial Locations

Locations (4)

Almirall investigative site 2; 🇳🇱 Zutphen, Netherlands

Almirall investigative site 1; 🇳🇱 Enschede, Netherlands

Almirall investigative site 5; 🇩🇪 Koblenz, Germany

Almirall investigative site 3; 🇩🇪 Bonn, Germany