Greek NIS Spiolto ELLACTO

N/ACompletedNCT03419962

Boehringer Ingelheim1,360 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,360

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

MaxSpiolto® Respimat® 160 Characters...DRUG

as per the approved SmPC

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (15)

Metropolitan

Aegina, Greece

Metroplitan

Athens, Greece

Metropolitan

Athens, Greece

Outcomes

Primary Outcomes

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.

Time frame: 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

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.

Time frame: 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.

Data from ClinicalTrials.gov

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