Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment
This trial is active, not recruiting.
|Treatment||budesonide, formoterol fumarate dihydrate|
|Sponsor||Teva Pharma GmbH|
|Start date||July 2014|
|End date||March 2016|
|Trial size||4034 participants|
|Trial identifier||NCT02384577, BFS-AS-40074, DRKS00006542|
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.
Patient Satisfaction and Preference Questionnaire (PASAPQ)
time frame: 12 weeks
Practicability of the device
time frame: 12 weeks
Male or female participants at least 18 years old.
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
|Official title||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|
|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.|
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