At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,335 enrolled
Drug / intervention
Spioltodrug
Likely dose
Tiotropium+olodaterol 5µg/5µg (Spiolto)AI-extracted
Key inclusion· 2
- ✓Diagnosed with COPD (chronic bronchitis or emphysema) and need symptom relief with LABA or LAMA therapy
- ✓First-time prescription of tiotropium+olodaterol 5µg/5µg
Key exclusion· 3
- ✕Prior enrollment in this study (re-entry not allowed)
- ✕Concurrent participation in another registry or clinical trial
- ✕Contraindications to tiotropium+olodaterol as defined in the package insert
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating Spiolto for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 1,335 participants across 1 site.
Detailed 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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartAug 2016
Primary CompletionOct 2018
Study CompletionNov 2018
TodayJul 2026
First PostedAug 1, 2016
Enrollment StartAug 23, 2016
Primary CompletionOct 30, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.9 years ago
Interventions
Spioltodrug