Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
This study has been completed.
Sponsor:
Almirall, S.A.
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
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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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013