Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.
Study Type
OBSERVATIONAL
Enrollment
4,819
Drug
Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2
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.
Time frame: At Visit 2 (6 weeks after baseline visit 1)
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to 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.
Time frame: At baseline visit 1 and 6 weeks thereafter at visit 2
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Time frame: At visit 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MBAL Sveti Ivan Rilski-2003
Dupnitsa, Bulgaria
SBALBB "Pencho Semov" - Gabrovo EOOD
Gabrovo, Bulgaria
SBALPFZ Haskovo EOOD
Haskovo, Bulgaria
MBAL Kiro Popov EOOD
Karlovo, Bulgaria
MBAL Sv. Ivan Rilski EOOD
Kozloduy, Bulgaria
MBAL "Prof. Dr P. Stoyanov" AD - Mihail Kirov
Lovech, Bulgaria
Iliana Valkanova
Plovdiv, Bulgaria
MBAL Sveti Panteleimon
Plovdiv, Bulgaria
"Medical Center-Razgrad"OOD
Razgrad, Bulgaria
Medical Center Re Spiro OOD
Razgrad, Bulgaria
...and 378 more locations
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Time frame: At visit 2 (6 weeks after baseline visit 1)
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.
Time frame: At visit 2 (6 weeks after baseline visit 1)
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported
Time frame: At visit 2 (6 weeks after baseline visit 1)
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.
Time frame: At visit 2 (6 weeks after baseline visit 1)
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.
Time frame: At visit 2 (6 weeks after baseline visit 1)