Greek NIS Spiolto ELLACTO

NCT03419962 | Completed Results

• 1 other identifier: 1237-0073
• Study Type: observational
• Target: 1,360
• Locations: 1 country
• Sites: 15

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2

  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

  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

  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

  At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).

• Patients Preference for Spiolto® Respimat® at Visit 2

  At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)

Study Arms (1)

COPD patients

Chronic obstructive pulmonary disease

Drug: MaxSpiolto® Respimat® 160 Characters...

Interventions

MaxSpiolto® Respimat® 160 Characters... DRUG

as per the approved SmPC

Also known as: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

COPD patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (15)

Metropolitan

Aegina, 18547, Greece

Location

Metroplitan

Athens, 18547, Greece

Location

Metropolitan

Athens, 18547, Greece

Location

Metropolitan

Chania, 18547, Greece

Location

Metropolitan

Heraklio, 18547, Greece

Location

Metropolitan

Hrakleio, 18547, Greece

Location

Metropolitan

Hraklio, 18547, Greece

Location

Diavalkaniko

Ioannina, 55535, Greece

Location

Diavalkaniko

Kavala, 55535, Greece

Location

Diavalkaniko

Larissa, 55535, Greece

Location

Metropolitan

Pátrai, 18547, Greece

Location

Diavalkaniko

Serres, 55535, Greece

Location

Merkouropoulos Markos

Thessaloniki, 54629, Greece

Location

Diavalkaniko

Thessaloniki, 55535, Greece

Location

Diavalkaniko

Volos, 55535, Greece

Location

Related Publications (1)

• 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.

  PMID: 33939158 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: March 19, 2018
• Primary Completion: November 9, 2018
• Study Completion: April 3, 2019
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Locations

GR (15)