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

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ClinicalTrials.gov Identifier: NCT01385696
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : April 22, 2013
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.

Study Description
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Brief Summary:
Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: Genuair® (Almirall S.A.) Device: HandiHaler® (Boehringer Ingelheim's) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: group A
Genuair first, HandiHaler second
 Device: Genuair® (Almirall S.A.)
Inhaler with only placebo, once daily, 14 days

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

Device: HandiHaler® (Boehringer Ingelheim's)
Inhaler with only placebo, once daily, 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 [ Time Frame: 14 days ]
    Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)


Secondary Outcome Measures :
  1. Mean Overall Satisfaction With Genuair and Handihaler at Visit 2 [ Time Frame: 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)

  2. Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2 [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385696


Locations
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Germany
Almirall investigative site 3
Bonn, Germany, 53119
Almirall investigative site 5
Koblenz, Germany, 56068
Netherlands
Almirall investigative site 1
Enschede, Netherlands, 7511 JX
Almirall investigative site 2
Zutphen, Netherlands, 7207 AE
Sponsors and Collaborators
Almirall, S.A.
Investigators
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Study Director: Jordi Estruch, Head of GMA Almirall, S.A.
More Information
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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01385696    
Other Study ID Numbers: M/34273/32
First Posted: June 30, 2011    Key Record Dates
Results First Posted: April 22, 2013
Last Update Posted: June 24, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases