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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    600
  • sponsor
    Boehringer Ingelheim
Updated on 28 May 2021
Investigator
Boehringer Ingelheim Call Center
Primary Contact
Praxis Dr. Schmorell (0.4 mi away) Contact
+130 other location
corticosteroids
dyspnea
muscarinic antagonists
tiotropium
olodaterol

Summary

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

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.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease)
Treatment Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist, Tripple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist, Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids
Clinical Study IdentifierNCT03954132
SponsorBoehringer Ingelheim
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note