N/A
Completed N=1,335
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02850978 ↗
Enrolled (actual)
1,335
Serious AEs
7.4%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reactions — 3.93 Percentage of participants (%)
Summary
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions |
3.93 | — |
| SECONDARY Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 |
-3.7 | — |
Eligibility Criteria
Inclusion criteria
- Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA).
- Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time
Exclusion criteria
- Patients who have been registered once in this study (i.e., re-entry of patients is not allowed).
- Patients who are participating in a registry or clinical trial.
- Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.
Data sourced from ClinicalTrials.gov (NCT02850978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.