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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01385696
First received: June 17, 2011
Last updated: March 12, 2013
Last verified: July 2012
  Purpose

Preference study: Genuair vs HandiHaler inhalers in COPD patients.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)


Secondary Outcome Measures:
  • Mean Overall Satisfaction With Genuair and Handihaler at Visit 2 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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)

  • Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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.



Enrollment: 130
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385696

Locations
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
Study Director: Jordi Estruch, Head of GMA Almirall, S.A.
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01385696     History of Changes
Other Study ID Numbers: M/34273/32
Study First Received: June 17, 2011
Results First Received: January 14, 2013
Last Updated: March 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014