Greek NIS Spiolto ELLACTO

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419962
• Other study ID #: 1237-0073
• Status: Completed
• Start date: March 19, 2018
• Est. completion date: April 3, 2019

Study information

• Verified date: April 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: April 3, 2019
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• MaxSpiolto® Respimat® 160 Characters...
as per the approved SmPC

Locations

Country	Name	City	State
Greece	Metropolitan	Aigina
Greece	Metroplitan	Athens
Greece	Metropolitan	Athens
Greece	Metropolitan	Chania
Greece	Metropolitan	Heraklio
Greece	Metropolitan	Hrakleio
Greece	Metropolitan	Hraklio
Greece	Diavalkaniko	Ioannina
Greece	Diavalkaniko	Kavala
Greece	Diavalkaniko	Larisa
Greece	Metropolitan	Patra
Greece	Diavalkaniko	Serres
Greece	Diavalkaniko	Thessaloniki
Greece	Merkouropoulos Markos	Thessaloniki
Greece	Diavalkaniko	Volos

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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)
Secondary	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).

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