Skip to main content
OpenTrials
Completed

NCT Number: NCT02384577

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teva Investigational Sites

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide, Formoterol Fumarate Dihydrate

Drug

Other names: DuoResp® Spiromax®

Primary outcomes

  1. Patient Satisfaction and Preference Questionnaire (PASAPQ)

    Time frame: 12 weeks

    Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ

  2. Practicability of the device

    Time frame: 12 weeks

    Investigation of practicability of the device for patients using checklist inhalation errors

Sponsors and collaborators

Lead sponsor

Teva Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2015
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.