Multicenter, Open-label, Non-interventional Study (NIS) to Evaluate Patient's Satisfaction and Preference, the Usability of DuoResp® SPIROMAX® and the Impact on Clinical Effects, in the Daily Routine of Asthma and COPD Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Budesonide, Formoterol Fumarate Dihydrate
- Conditions
- Patient Satisfaction
- Sponsor
- Teva Pharma GmbH
- Enrollment
- 4034
- Locations
- 1
- Primary Endpoint
- Practicability of the device
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single group prospective treatment
Intervention: Budesonide, Formoterol Fumarate Dihydrate
Outcomes
Primary Outcomes
Practicability of the device
Time Frame: 12 weeks
Investigation of practicability of the device for patients using checklist inhalation errors
Patient Satisfaction and Preference Questionnaire (PASAPQ)
Time Frame: 12 weeks
Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ