Clinical trial NCT03419962: Greek NIS Spiolto ELLACTO
Official title: Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) During Therapy With Spiolto® Respimat® [ELLACTO]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 1360
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1300 patients with chronic obstructive pulmonary disease (COPD) in whom combination treatment with long-acting bronchodilators is indicated in accordance with the guidelines are to be observed by approx. 100 pulmonologists in the setting of private practice. The NIS will take place in Greece and sites in urban as well as rural areas will be included. The nationwide distribution of the participating pulmonologists as well as the number of patients enrolled are intended to ensure that the data collected are representative.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score
timeFrame: Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).
Secondary outcomes:
measure: Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2
timeFrame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).
measure: Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2
timeFrame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).
measure: General Condition of Patient at Visit 1 and Visit 2
timeFrame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).
measure: Patients Satisfaction With Spiolto® Respimat® at Visit 2
timeFrame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).
measure: Patients Preference for Spiolto® Respimat® at Visit 2
timeFrame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)
measure: Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2
timeFrame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).
Other outcomes:
Locations:
city: Aigina
country: Greece
facility: Metropolitan
city: Athens
country: Greece
facility: Metroplitan
city: Athens
country: Greece
facility: Metropolitan
city: Chania
country: Greece
facility: Metropolitan
city: Heraklio
country: Greece
facility: Metropolitan
city: Hrakleio
country: Greece
facility: Metropolitan
city: Hraklio
country: Greece
facility: Metropolitan
city: Ioannina
country: Greece
facility: Diavalkaniko
city: Kavala
country: Greece
facility: Diavalkaniko
city: Larisa
country: Greece
facility: Diavalkaniko
city: Patra
country: Greece
facility: Metropolitan
city: Serres
country: Greece
facility: Diavalkaniko
city: Thessaloniki
country: Greece
facility: Merkouropoulos Markos
city: Thessaloniki
country: Greece
facility: Diavalkaniko
city: Volos
country: Greece
facility: Diavalkaniko
Study officials:
References:
citation: Kosmas E, Titopoulos I, Patentalakis G, Nikas N. An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive Pulmonary Disease (COPD) During Therapy with Spiolto(R) Respimat(R) in Everyday Clinical Practice: The Greek ELLACTO Study. Pulm Ther. 2021 Dec;7(2):429-443. doi: 10.1007/s41030-021-00156-7. Epub 2021 May 3.