Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
1 other identifier
interventional
130
2 countries
4
Brief Summary
Preference study: Genuair vs HandiHaler inhalers in COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2011
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
April 22, 2013
CompletedJune 24, 2015
May 1, 2015
7 months
June 17, 2011
January 14, 2013
May 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Mean Overall Satisfaction With Genuair and Handihaler at Visit 2
14 days
Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2
14 days
Study Arms (2)
group A
EXPERIMENTALGenuair first, HandiHaler second
group B
EXPERIMENTALHandiHaler first, Genuair second
Interventions
Inhaler with only placebo, once daily, 14 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Almirall, S.A.lead
Study Sites (4)
Almirall investigative site 3
Bonn, 53119, Germany
Almirall investigative site 5
Koblenz, 56068, Germany
Almirall investigative site 1
Enschede, 7511 JX, Netherlands
Almirall investigative site 2
Zutphen, 7207 AE, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Leader and Trial Manager
- Organization
- Almirall S.A.
Study Officials
- STUDY DIRECTOR
Jordi Estruch, Head of GMA
Almirall, S.A.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 24, 2015
Results First Posted
April 22, 2013
Record last verified: 2015-05