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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385696
• Other study ID #: M/34273/32
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2011
• Last updated: May 28, 2015
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Genuair® (Almirall S.A.)
Inhaler with only placebo, once daily, 14 days
• HandiHaler® (Boehringer Ingelheim's)
Inhaler with only placebo, once daily, 14 days

Locations

Country	Name	City	State
Germany	Almirall investigative site 3	Bonn
Germany	Almirall investigative site 5	Koblenz
Netherlands	Almirall investigative site 1	Enschede
Netherlands	Almirall investigative site 2	Zutphen

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2	Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)	14 days	No
Secondary	Mean Overall Satisfaction With Genuair and Handihaler at Visit 2	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	No
Secondary	Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2	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	No