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

Sponsor
Teva Pharma GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT02384577
Collaborator
(none)
4,034
1
26.1
154.8

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Jul 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Single group prospective treatment

Drug: Budesonide, Formoterol Fumarate Dihydrate
Other Names:
  • DuoResp® Spiromax®
  • Outcome Measures

    Primary Outcome Measures

    1. Patient Satisfaction and Preference Questionnaire (PASAPQ) [12 weeks]

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

    2. Practicability of the device [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Sites Berlin Germany

    Sponsors and Collaborators

    • Teva Pharma GmbH

    Investigators

    • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Pharma GmbH
    ClinicalTrials.gov Identifier:
    NCT02384577
    Other Study ID Numbers:
    • BFS-AS-40074
    • DRKS00006542
    First Posted:
    Mar 10, 2015
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021