4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)

Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)

Study Description
Brief Summary:
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids

Detailed Description:
COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EVELUT®: Assessment of Dyspnea and Other Symptoms as Patient Reported Outcomes (PRO) in Patients With Chronic Obstructive Pulmonary Disease (COPD), Symptomatic on LABA/ICS Maintenance Therapy (Now) Treated With Spiolto® Respimat® (Tiotropium/Olodaterol) in Comparison to Open or Fixed Triple Combination Treatment in Routine Clinical Practice
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Subject with Chronic Obstructive pulmonary disease Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist
LAMA+LABA
Other Name: Spiolto® Respimat®

Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids
(LAMA+LABA+ Inhalative Corticosteroids (ICS)
Other Name: LAMA+LABA+ Inhalative Corticosteroids (ICS)

Outcome Measures
Primary Outcome Measures :
  1. Difference between modified Medical Research Council score at baseline (visit 1) and mMRC score after end of observation [ Time Frame: 12 weeks ]
    The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea

  2. Difference between CAT score at baseline (visit 1) and CATTM score after end after end of observation [ Time Frame: 12 weeks ]
    The COPD Assessment Test (CAT TM) consists of eight items -cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. CAT TM is a trademark.


Secondary Outcome Measures :
  1. patient's general condition according to the Physician's Global Evaluation (PGE) score at baseline and end of the observation period [ Time Frame: upto 12 weeks ]
    PGE evaluates the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent) before and approx. 12 weeks after treatment initiation

  2. patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied as documented in non-interventional BI studies [ Time Frame: upto 12 weeks ]
    A7-item satisfaction scale with divisions from very dissatisfied to very satisfied to measure patient satisfaction with inhaler use, is a Likert-scale without validation status for the intended use

  3. proportion of responders with mMRC ≥1 and the proportion of responders with CAT ≥2 [ Time Frame: upto 12 weeks ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study is based on newly collected data from approximately 900 COPD patients from 150 recruiting sites in Germany.
Criteria

Inclusion Criteria:

Patients can be included if all of the following criteria are met:

  • Diagnosis of COPD
  • Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
  • Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
  • Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
  • Male or female
  • Patients aged ≥40 years of age
  • Written informed consent prior to study participation
  • The patient is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

  • Patients with contraindications acc. to SmPC
  • Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
  • Lack of informed consent
  • Pregnant and/or lactating females
  • Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
  • Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
  • Acute respiratory failure (pH <7,35 and/ or respiratory rate >30/min within 3 months prior to Visit 1)
  • History or current diagnosis of asthma
  • History or current diagnosis of asthma-COPD overlap
  • History or current diagnosis of allergic rhinitis within the last 5 years
  • History or current diagnosis of lung cancer within the last 5 years
  • Participation in a parallel interventional clinical trial
  • mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
  • moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
  • severe exacerbation: exacerbation leading to hospitalization
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Show Show 76 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Andrea Marseille, 0049613277141881 andrea.marseille@boehringer-ingelheim.com
Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 17, 2019
Last Update Posted Date May 19, 2021
Actual Study Start Date June 7, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019)
  • Difference between modified Medical Research Council score at baseline (visit 1) and mMRC score after end of observation [ Time Frame: 12 weeks ]
    The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea
  • Difference between CAT score at baseline (visit 1) and CATTM score after end after end of observation [ Time Frame: 12 weeks ]
    The COPD Assessment Test (CAT TM) consists of eight items -cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. CAT TM is a trademark.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2019)
  • patient's general condition according to the Physician's Global Evaluation (PGE) score at baseline and end of the observation period [ Time Frame: upto 12 weeks ]
    PGE evaluates the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent) before and approx. 12 weeks after treatment initiation
  • patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied as documented in non-interventional BI studies [ Time Frame: upto 12 weeks ]
    A7-item satisfaction scale with divisions from very dissatisfied to very satisfied to measure patient satisfaction with inhaler use, is a Likert-scale without validation status for the intended use
  • proportion of responders with mMRC ≥1 and the proportion of responders with CAT ≥2 [ Time Frame: upto 12 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Official Title EVELUT®: Assessment of Dyspnea and Other Symptoms as Patient Reported Outcomes (PRO) in Patients With Chronic Obstructive Pulmonary Disease (COPD), Symptomatic on LABA/ICS Maintenance Therapy (Now) Treated With Spiolto® Respimat® (Tiotropium/Olodaterol) in Comparison to Open or Fixed Triple Combination Treatment in Routine Clinical Practice
Brief Summary Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
Detailed Description COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study is based on newly collected data from approximately 900 COPD patients from 150 recruiting sites in Germany.
Condition Pulmonary Disease, Chronic Obstructive
Intervention
  • Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist
    LAMA+LABA
    Other Name: Spiolto® Respimat®
  • Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids
    (LAMA+LABA+ Inhalative Corticosteroids (ICS)
    Other Name: LAMA+LABA+ Inhalative Corticosteroids (ICS)
Study Groups/Cohorts Subject with Chronic Obstructive pulmonary disease
Interventions:
  • Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist
  • Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids
Publications * Buhl R, Dreher M, Korn S, Taube C, Stock C, Zehendner CM, Kondla A, Vogelmeier CF. A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT(®) Study Protocol. Int J Chron Obstruct Pulmon Dis. 2020 Oct 22;15:2601-2608. doi: 10.2147/COPD.S262746. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 19, 2021)
600
Original Estimated Enrollment
 (submitted: May 15, 2019)
900
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients can be included if all of the following criteria are met:

  • Diagnosis of COPD
  • Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
  • Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
  • Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
  • Male or female
  • Patients aged ≥40 years of age
  • Written informed consent prior to study participation
  • The patient is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

  • Patients with contraindications acc. to SmPC
  • Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
  • Lack of informed consent
  • Pregnant and/or lactating females
  • Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
  • Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
  • Acute respiratory failure (pH <7,35 and/ or respiratory rate >30/min within 3 months prior to Visit 1)
  • History or current diagnosis of asthma
  • History or current diagnosis of asthma-COPD overlap
  • History or current diagnosis of allergic rhinitis within the last 5 years
  • History or current diagnosis of lung cancer within the last 5 years
  • Participation in a parallel interventional clinical trial
  • mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
  • moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
  • severe exacerbation: exacerbation leading to hospitalization
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03954132
Other Study ID Numbers 1237-0087
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Andrea Marseille, 0049613277141881 andrea.marseille@boehringer-ingelheim.com
PRS Account Boehringer Ingelheim
Verification Date May 2021

治疗医院