Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment
Completed
- Conditions
- Patient Satisfaction
- Interventions
- Drug: Budesonide, Formoterol Fumarate Dihydrate
- Registration Number
- NCT02384577
- Lead Sponsor
- Teva Pharma GmbH
- Brief Summary
The main aim of the study is to investigate patient satisfaction in the treatment of asthma and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.
- Detailed Description
The study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or COPD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4034
Inclusion Criteria
- male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
- patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
- patients who recently changed medication to DuoResp® Spiromax or are about to do so
- capacitated person with present declaration of consent
Exclusion Criteria
- diseases contraindicated in accordance with the summary of product characteristic
- patients who take part in interventional clinical trials parallel or during the last 4 weeks
- patient shows conditions or diseases that might disturb the monitoring according to the physician
- patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
- insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
- patients involved in the planning and construction of the study (Teva staff and employees of the centres)
- patient is incapable of giving consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single group prospective treatment Budesonide, Formoterol Fumarate Dihydrate -
- Primary Outcome Measures
Name Time Method Practicability of the device 12 weeks Investigation of practicability of the device for patients using checklist inhalation errors
Patient Satisfaction and Preference Questionnaire (PASAPQ) 12 weeks Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Teva Investigational Sites
🇩🇪Berlin, Germany