Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment

Teva Pharmaceuticals

Status: Completed

Conditions: Patient Satisfaction

Treatments: Drug: Budesonide, Formoterol Fumarate Dihydrate

Study type: Observational

Funder types: Industry

Identifiers

NCT02384577

DRKS00006542 (Registry Identifier)

BFS-AS-40074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,034 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,034 participants in 1 patient group

Single group prospective treatment

Treatment:

Drug: Budesonide, Formoterol Fumarate Dihydrate