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

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ClinicalTrials.gov Identifier: NCT03954132
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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: Tripple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist

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.

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Study Type : Observational
Estimated Enrollment : 900 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
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Olodaterol

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: Tripple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist
(LAMA+LABA+ Inhalative Corticosteroides (ICS)
Other Name: LAMA+LABA+ Inhalative Corticosteroides (ICS)




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 ]


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:   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

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 ClinicalTrials.gov identifier (NCT number): NCT03954132


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03954132     History of Changes
Other Study ID Numbers: 1237-0087
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (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:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html 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 http://trials.boehringeringelheim.com/ 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
Statistical Analysis Plan (SAP)
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://trials.boehringer‐ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Olodaterol
Cholinergic Agents
Muscarinic Antagonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action