Newswires
Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data: Lung Diseases and Conditions – Chronic Obstructive Pulmonary Disease
2022 JUN 13 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT05393245 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •Incidence rate of adverse events in patients with COPD treated with Tio+Olo [ Time Frame: up to 5 years ] |
| Current Secondary Outcome Measures | •Baseline characteristics of patients who initiated Tio+Olo or other LAMA/LABA [ Time Frame: up to 5 years ] |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT05393245 |
Descriptive Information
| Brief Title | Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in |
| Official Title | Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in |
| Brief Summary | The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo). |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | Not Provided |
| Study Design | Observational Model: Cohort |
| Time Perspective: Retrospective | |
| Condition | Pulmonary Disease, Chronic Obstructive |
| Intervention | •Drug: Tiotropium+Olodaterol |
| Tiotropium+Olodaterol | |
| •Device: Spiolto Respimat | |
| Spiolto Respimat Inhaler device | |
| •Drug: Long-acting muscarinic antagonists (LAMAs) | |
| Long-acting muscarinic antagonists (LAMAs) | |
| •Drug: Long-acting b2-agonists (LABAs) | |
| Long-acting b2-agonists (LABAs) | |
| Study Arms | •COPD patients treated with tiotropium and olodaterol (Tio+Olo) |
| Interventions: | |
| ⚬Drug: Tiotropium+Olodaterol | |
| ⚬Device: Spiolto Respimat | |
| •COPD patients using other Long-acting muscarinic antagonists/Long-acting b2-ago | |
| Interventions: | |
| ⚬Drug: Long-acting muscarinic antagonists (LAMAs) | |
| ⚬Drug: Long-acting b2-agonists (LABAs) |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 4000 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | Patients treated with Tio+Olo: Inclusion criteria: At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 40 years and older |
| No | |
| Contacts | Primary contact: |
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT05393245 |
| Other Study ID Numbers | 1237-0109 |
| Has Data Monitoring Committee | Not Provided |
| Studies a |
|
| Studies a |
|
| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | Clinical studies sponsored by |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Information Provided By | |
| Verification Date |
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