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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02384577

Enrollment

4034

Registered

2015-03-10

Start date

2014-07-31

Completion date

2016-09-30

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction

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.

Interventions

DRUGBudesonide, Formoterol Fumarate Dihydrate

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Satisfaction and Preference Questionnaire (PASAPQ)	12 weeks	Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ
Practicability of the device	12 weeks	Investigation of practicability of the device for patients using checklist inhalation errors

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026