A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
- Registration Number
- NCT03663569
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4819
- Written informed consent prior to participation
- Female and male patients ≥40 years of age
- Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
- 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
- Pregnancy and lactation
- Current participation in any clinical trial or any other non-interventional study of a drug or device.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description subjects with COPD Spiolto® Respimat® -
- Primary Outcome Measures
Name Time Method Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 At Visit 2 (6 weeks after baseline visit 1) 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.
- Secondary Outcome Measures
Name Time Method 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 At baseline visit 1 and 6 weeks thereafter at 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.
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) At visit 1 PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Physician's Global Evaluation (PGE) Score at Visit 2 At visit 2 (6 weeks after baseline visit 1) PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 At visit 2 (6 weeks after baseline visit 1) Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 At visit 2 (6 weeks after baseline visit 1) Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 At visit 2 (6 weeks after baseline visit 1) Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 At visit 2 (6 weeks after baseline visit 1) Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.
Trial Locations
- Locations (386)
MBAL Sveti Ivan Rilski-2003
🇧🇬Dupnitza, Bulgaria
SBALBB "Pencho Semov" - Gabrovo EOOD
🇧🇬Gabrovo, Bulgaria
SBALPFZ Haskovo EOOD
🇧🇬Haskovo, Bulgaria
MBAL Kiro Popov EOOD
🇧🇬Karlovo, Bulgaria
MBAL Sv. Ivan Rilski EOOD
🇧🇬Kozloduj, 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
Scroll for more (376 remaining)MBAL Sveti Ivan Rilski-2003🇧🇬Dupnitza, Bulgaria