Pulmonary Disease, Chronic Obstructive
Conditions
Brief 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
Interventions
DRUGSpiolto
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | 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. |
Countries
Japan
Participant flow
Recruitment details
This was an observational study based on newly collected data under real-world practice in participants diagnosed with chronic obstructive pulmonary disease (COPD) (chronic bronchitis, emphysema) in Japan.
Pre-assignment details
This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline, concomitant drug in use) were defined for participant enrollment. Participants were enrolled from August 2016 to August 2017.
Participants by arm
| Arm | Count |
|---|---|
| Spiolto® Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration. | 1,273 |
| Total | 1,273 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 81 |
| Overall Study | Improvement in condition | 34 |
| Overall Study | Lack of Efficacy | 40 |
| Overall Study | Lost to Follow-up | 121 |
| Overall Study | No visit since the first visit | 35 |
| Overall Study | Reason not listed | 88 |
| Overall Study | Uncollectable CRF | 27 |
Baseline characteristics
| Characteristic | Spiolto® | — |
|---|---|---|
| Age, Continuous | 73.3 Years STANDARD_DEVIATION 9.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 206 Participants | — |
| Sex: Female, Male Male | 1067 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 38 / 1,273 |
| other Total, other adverse events | 0 / 1,273 |
| serious Total, serious adverse events | 94 / 1,273 |
Outcome results
Primary
Percentage of Participants With Adverse Drug Reactions
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.
Time frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
Population: Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiolto® | Percentage of Participants With Adverse Drug Reactions | 3.93 Percentage of participants (%) |
Secondary
Change of COPD Assessment Test (CAT) Score From Baseline to 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.
Time frame: Baseline and Week 12
Population: Effectiveness set: The effectiveness set included all patients in the safety set except for those patients who had no any values of CAT, Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) after Spiolto® Respimat® administration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiolto® | Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | -3.7 Unit on a scale | Standard Deviation 7.1 |