Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Patients With COPD
NCT ID: NCT01915784
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2013-07-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Group A
Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second
Genuair®
Inhaler with placebo only. Once daily, for 14 days.
Breezhaler®
Inhaler with placebo only. Once daily, for 14 days.
Group B
Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second
Genuair®
Inhaler with placebo only. Once daily, for 14 days.
Breezhaler®
Inhaler with placebo only. Once daily, for 14 days.
Interventions
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Genuair®
Inhaler with placebo only. Once daily, for 14 days.
Breezhaler®
Inhaler with placebo only. Once daily, for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Jordi Estruch, MD
Role: STUDY_DIRECTOR
Almirall, S.A.
Locations
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Almirall investigative site 2
Berlin, , Germany
Almirall investigative site 1
Munich, , Germany
Almirall investigative site 3
Barcelona, , Spain
Almirall investigative site 4
Palma de Mallorca, , Spain
Almirall investigative site 5
Glasgow, , United Kingdom
Almirall investigative site 6
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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M/34273/41
Identifier Type: -
Identifier Source: org_study_id