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

NCT ID: NCT02384577

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4034 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Patient Satisfaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single group prospective treatment

Budesonide, Formoterol Fumarate Dihydrate

Intervention Type DRUG

Interventions

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Budesonide, Formoterol Fumarate Dihydrate

Intervention Type DRUG

Other Intervention Names

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DuoResp® Spiromax®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Sites

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DRKS00006542

Identifier Type: REGISTRY

Identifier Source: secondary_id

BFS-AS-40074

Identifier Type: -

Identifier Source: org_study_id