Trial document




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  DRKS00006542

Trial Description

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Title

DuoResp Spiromax® in the daily therapy of asthma and COPD. A non-interventional study of satisfaction, preference and user friendliness as well as of the clinical efficacy profile.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The main objective of the study is to evaluate how satisfied patients with asthma or chronic obstructive pulmonary disease are with the new inhaler DuoResp Spiromax® and which inhalers they prefere. Furthermore potential difficulties in the use of the inhaler under daily life conditions are explored. In addition, the study investigates the training effort for the inhaler, the reasons for the switch and the adjustment of asthma and chronic obstructive pulmonary disease respectively.

After the baseline documentation patients are observed for 3 months at 3 visits: a baseline visit, an interim visit after ca. 4 weeks and a conclusion visit after ca. 12 weeks.

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Brief Summary in Scientific Language

The main objective of the study is to evaluate how satisfied patients with asthma or COPD are with the new inhaler DuoResp Spiromax® and which inhalers they prefere. Furthermore potential difficulties in the use of the inhaler under daily life conditions are explored. In addition, the study investigates the training effort for the inhaler, the reasons for the switch and the adjustment of asthma and COPD respectively.

After the baseline documentation patients are observed for 3 months at 3 visits: a baseline visit, an interim visit after ca. 4 weeks and a conclusion visit after ca. 12 weeks.

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Organizational Data

  •   DRKS00006542
  •   2014/07/30
  •   [---]*
  •   no
  •   Approved
  •   FF 67/2014, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J45 -  Asthma
  •   J44 -  Other chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   DuoResp Spiromax® should be taken according to the instructions in the summary of product characteristics.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

• Evaluation of satisfaction and preference of patients who use DuoResp Spiromax® (using the "Satisfaction With Inhalers and Preference Questionnaire" (SWIP), at baseline and after ca. 12 weeks)
• Collection of patient-individual handling errors of the device (using an adapted "Easy Low Instruction Over Time" questionnaire (ELIOT), at baseline and after ca. 12 weeks)

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Secondary Outcome

• Collection of the training effort (at baseline)
• Evaluation of the clinical effectiveness of DuoResp Spiromax® with regard to obtaining or maintenance of asthma or COPD control (using the Asthma Control Test™/COPD Assessment Test™ questionnaire, at baseline, after ca. 4 weeks and after ca. 12 weeks)
• Documentation of the reasons for the prescription of the inhaler system DuoResp® Spiromax® and the reasons for the switch from a previous product

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2014/07/28
  •   4000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1) Adult male or female patients (≥ 18 years) with confirmed diagnosis of asthma bronchiale or COPD
2) Patients with indication of a regular intake of a combination of inhalative corticosteroids and long-acting β2 adrenergic receptor agonists
3) Patients who are currently receiving or a switched to DuoResp Spiromax®
4) Written informed consent

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Exclusion Criteria

1) Diseases which are contraindicated according to the summary of product characteristics
2) Parallel participation in an interventional clinical trial or participation within the last 4 weeks
3) Upon investigator assessment patient suffers from diseases or there are other conditions which could have a negative impact on the course of the observation
4) Patients with medical history of substance abuse (drugs, alcohol) or with other factors (e.g. serious psychiatric disease) which limit the patient's capacity to take part in the study activities
5) Insufficient German language skills to understand the consent process and to complete the questionnaires correctly
6) Patients who were or are involved in the planning and execution of the study (applicable for Teva employees and study site staff)
7) Patient is not able to give his/her consent

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Addresses

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    • TEVA GmbH
    • Charlottenstr. 59
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Teva GmbH
    • Ms.  Dr. med.  Regina  Schneidereit 
    • Charlottenstr. 59
    • 10117  Berlin
    • Germany
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  • start of 1:1-Block address public-contact
    • Teva GmbH
    • Ms.  Dr. med.  Regina  Schneidereit 
    • Charlottenstr. 59
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Teva GmbH
    • Charlottenstr. 59
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/21
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.