Greek NIS Spiolto ELLACTO

Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) During Therapy With Spiolto® Respimat® [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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: MaxSpiolto® Respimat® 160 Characters...

• Study Type: Observational
• Enrollment (Actual): 1360

Contacts and Locations

Study Locations

• Greece
  • Aigina, Greece, 18547
    • Metropolitan
  • Athens, Greece, 18547
    • Metroplitan
  • Athens, Greece, 18547
    • Metropolitan
  • Chania, Greece, 18547
    • Metropolitan
  • Heraklio, Greece, 18547
    • Metropolitan
  • Hrakleio, Greece, 18547
    • Metropolitan
  • Hraklio, Greece, 18547
    • Metropolitan
  • Ioannina, Greece, 55535
    • Diavalkaniko
  • Kavala, Greece, 55535
    • Diavalkaniko
  • Larisa, Greece, 55535
    • Diavalkaniko
  • Patra, Greece, 18547
    • Metropolitan
  • Serres, Greece, 55535
    • Diavalkaniko
  • Thessaloniki, Greece, 54629
    • Merkouropoulos Markos
  • Thessaloniki, Greece, 55535
    • Diavalkaniko
  • Volos, Greece, 55535
    • Diavalkaniko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD patients; Chronic obstructive pulmonary disease	Drug: MaxSpiolto® Respimat® 160 Characters...; as per the approved SmPC; Other Names: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score	Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score.	Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2	Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status.	At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).
Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2	Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status.	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).
General Condition of Patient at Visit 1 and Visit 2	General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8).	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).
Patients Satisfaction With Spiolto® Respimat® at Visit 2	The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions.	At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).
Patients Preference for Spiolto® Respimat® at Visit 2	Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions.	At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)
Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2	Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it.	At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ACTUAL): November 9, 2018
• Study Completion (ACTUAL): April 3, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1237-0073