Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Comparison to a Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Berodual® Respimat® - inhaler
- Registration Number
- NCT02231346
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Male and female patients aged at least 18 years
- Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
- During the PMS the Diskus® therapy is to be continued
Exclusion Criteria
- Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description chronic obstructive pulmonary disease patients Berodual® Respimat® - inhaler -
- Primary Outcome Measures
Name Time Method Number of patients with adverse events up to 4 weeks Number of patients who prematurely discontinued therapy with Berodual® Respimat® up to 4 weeks
- Secondary Outcome Measures
Name Time Method Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler up to 4 weeks by means of a patient satisfaction and preference questionnaire (PASAPQ)
Assessment of patient satisfaction with regard to handling of Diskus® inhaler Baseline by means of patient satisfaction and preference questionnaire (PASAPQ)