J45 J44
Conditions
Interventions
Group 1: DuoResp Spiromax® should be taken according to the instructions in the summary of product characteristics.
Sponsors
TEVA GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Adult male or female patients (= 18 years) with confirmed diagnosis of asthma bronchiale or COPD 2) Patients with indication of a regular intake of a combination of inhalative corticosteroids and long-acting ß2 adrenergic receptor agonists 3) Patients who are currently receiving or a switched to DuoResp Spiromax® 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Diseases which are contraindicated according to the summary of product characteristics 2) Parallel participation in an interventional clinical trial or participation within the last 4 weeks 3) Upon investigator assessment patient suffers from diseases or there are other conditions which could have a negative impact on the course of the observation 4) Patients with medical history of substance abuse (drugs, alcohol) or with other factors (e.g. serious psychiatric disease) which limit the patient's capacity to take part in the study activities 5) Insufficient German language skills to understand the consent process and to complete the questionnaires correctly 6) Patients who were or are involved in the planning and execution of the study (applicable for Teva employees and study site staff) 7) Patient is not able to give his/her consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Evaluation of satisfaction and preference of patients who use DuoResp Spiromax® (using the "Satisfaction With Inhalers and Preference Questionnaire" (SWIP), at baseline and after ca. 12 weeks) • Collection of patient-individual handling errors of the device (using an adapted "Easy Low Instruction Over Time" questionnaire (ELIOT), at baseline and after ca. 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Collection of the training effort (at baseline) • Evaluation of the clinical effectiveness of DuoResp Spiromax® with regard to obtaining or maintenance of asthma or COPD control (using the Asthma Control Test™/COPD Assessment Test™ questionnaire, at baseline, after ca. 4 weeks and after ca. 12 weeks) • Documentation of the reasons for the prescription of the inhaler system DuoResp® Spiromax® and the reasons for the switch from a previous product | — |
Countries
Germany
Contacts
Public ContactRegina Schneidereit
Teva GmbH
Outcome results
None listed