Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02850978|
Recruitment Status : Completed
First Posted : August 1, 2016
Results First Posted : December 6, 2019
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Drug: Spiolto|
|Study Type :||Observational|
|Actual Enrollment :||1335 participants|
|Official Title:||Post-marketing Surveillance (PMS) on Long-term Use of Tiotropium+Olodaterol Fixed Dose Combination (Tio+Olo FDC) 5µg/5µg in Patients With Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) in Japan|
|Actual Study Start Date :||August 23, 2016|
|Actual Primary Completion Date :||October 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
Patient with COPD to received Spiolto
- Percentage of Participants With Adverse Drug Reactions [ Time Frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. ]Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".
- Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850978
|Multiple Locations, Japan|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|