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Greek NIS Spiolto ELLACTO | Clinical Trials | Clareo Health

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COMPLETEDNCT03419962

Greek NIS Spiolto ELLACTO

Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations

Lead sponsor: Boehringer Ingelheim•15 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Boehringer Ingelheim

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Therapeutic indication before entering the enrollment face is patients diagnosed with COPD requiring a combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and guidelines, COPD GOLD 2017 groups B to D
•Female and male patients ≥40 years of age
•Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician
•Written informed consent prior to participation

Exclusion Criteria

•Patients with contraindications according to Spiolto® Respimat® SmPC
•Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study
•Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
•Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
•Pregnancy and lactation
•Patients currently listed for lung transplantation
•Current participation in any clinical trial or any other non-interventional study of a drug or device

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 27, 2020Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment1,360

Start dateMar 2018

Last updatedApr 27, 2020

Condition

Pulmonary Disease, Chronic Obstructive

Locations shown

Metropolitan

Aegina

Metroplitan

Athens

Metropolitan

Athens

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2020Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions