Status:
COMPLETED
Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Patients With COPD
Lead Sponsor:
Almirall, S.A.
Collaborating Sponsors:
Forest Laboratories
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD
Eligibility Criteria
Inclusion
- Adult male or female patients aged ≥40 years with stable moderate-to-severe COPD according to the GOLD Guidelines classification (grades II and III): forced expiratory volume in 1 second (measured between 10 to 15 minutes post-inhalation of 400 μg of salbutamol) is 30%≤FEV1\<80% of the predicted normal value
- Patients naïve to both study inhaler devices, Genuair® and Breezhaler®, for at least 2 years
- Agreement to participate and voluntarily sign the informed consent form
Exclusion
- Patients with other clinically significant uncontrolled chronic diseases, particularly body malformations or diseases affecting coordination and/or motor system
- Patients unable to read product package instructions and answer patient reported questionnaires (PASAPQ)
- Patients with any other serious or uncontrolled mental health problems
- Patients currently participating in other randomised clinical studies
- Patients with COPD exacerbation within 6 weeks before Visit 1 and patient hospitalised for COPD exacerbation within 3 months prior to Visit 1
- Patients with any other conditions that, in the investigator's opinion, might indicate the patient to be inappropriate for the study
- Patient likely to be uncooperative
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01915784
Start Date
July 1 2013
End Date
October 1 2013
Last Update
May 29 2015
Active Locations (6)
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1
Almirall investigative site 2
Berlin, Germany
2
Almirall investigative site 1
Munich, Germany
3
Almirall investigative site 3
Barcelona, Spain
4
Almirall investigative site 4
Palma de Mallorca, Spain