Greek NIS Spiolto ELLACTO

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).

Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both 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).

Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both 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.

Time frame: 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).

Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both 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).

Time frame: 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).

Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and 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.

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

Population: Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study.

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.

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

Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. Only 1330 patients completed the PASAPQ Part1+Part2.

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.

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

Population: Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study. Only 253 patients were analyzed, as one patient did not answer the question.