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

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384577
• Other study ID #: BFS-AS-40074
• Secondary ID: DRKS00006542
• Status: Completed
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4034
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Drug:
• Budesonide, Formoterol Fumarate Dihydrate

Locations

Country	Name	City	State
Germany	Teva Investigational Sites	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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