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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02384577
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharma GmbH )

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.

Condition or disease Intervention/treatment
Patient Satisfaction Drug: Budesonide, Formoterol Fumarate Dihydrate

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.

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Study Type : Observational
Actual Enrollment : 4034 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult asthma or COPD-patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02384577

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Teva Investigational Sites
Berlin, Germany
Sponsors and Collaborators
Teva Pharma GmbH
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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Responsible Party: Teva Pharma GmbH Identifier: NCT02384577    
Other Study ID Numbers: BFS-AS-40074
DRKS00006542 ( Registry Identifier: German Clinical Trials Register )
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action