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

November 5, 2021 updated by: Teva Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

4034

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Teva Investigational Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult asthma or COPD-patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single group prospective treatment
Drug: Budesonide, Formoterol Fumarate Dihydrate
Other Names:
  • DuoResp® Spiromax®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFS-AS-40074
  • DRKS00006542 (Registry Identifier: German Clinical Trials Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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