Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

The CCQ questionnaire 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 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.

Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.

Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.