N/A
Completed N=3,223
Vahelva Respimat Regulatory Post-marketing Surveillance in Korean Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02864407 ↗
Enrolled (actual)
3,223
Serious AEs
4.7%
Results posted
Jan 2022
Primary outcomePrimary: Percentage of Subjects With Any Adverse Event, Unexpected Adverse Event, Unexpected Serious Adverse Event, Adverse Event Leading to Discontinuation — 19.90; 13.65; 3.48; 2.29 percentage of participants
Summary
To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with COPD in a routine clinical practice setting
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Any Adverse Event, Unexpected Adverse Event, Unexpected Serious Adverse Event, Adverse Event Leading to Discontinuation |
19.90; 13.65; 3.48; 2.29 | — |
| PRIMARY Percentage of Subjects With Any Adverse Drug Reaction, Serious Adverse Drug Reaction, Unexpected Adverse Drug Reaction, Unexpected Serious Adverse Drug Reaction, Adverse Drug Reaction Leading to Discontinuation |
2.87; 0.16; 1.16; 0.13; 1.32 | — |
| PRIMARY Percentage of Subjects With Any Adverse Event (AE) in the Long-term Safety Analysis Set |
22.88 | — |
| PRIMARY Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24 in the Effectiveness Analysis Set |
5.41 | <0.0001 sig |
| PRIMARY Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 52 in the Effectiveness Analysis Set |
4.91 | <0.0001 sig |
| PRIMARY Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24 in the Long-term Effectiveness Analysis Set |
6.13 | <0.0001 sig |
| PRIMARY Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 52 in the Long-term Effectiveness Analysis Set |
4.83 | <0.0001 sig |
| SECONDARY Change From Baseline in Post Bronchodilator Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24 in the Effectiveness Analysis Set |
3.80 | <0.0001 sig |
| SECONDARY Change From Baseline in Post Bronchodilator Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 52 in the Effectiveness Analysis Set |
4.52 | <0.0001 sig |
| SECONDARY Change From Baseline in Post Bronchodilator Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24 in the Long-term Effectiveness Analysis Set |
5.19 | <0.0001 sig |
| SECONDARY Change From Baseline in Post Bronchodilator Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 52 in the Long-term Effectiveness Analysis Set |
4.36 | <0.0001 sig |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score at Week 24 in the Effectiveness Analysis Set |
-0.18 | <0.0001 sig |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score at Week 52 in the Effectiveness Analysis Set |
-0.39 | <0.0001 sig |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score at Week 24 in the Long-term Effectiveness Analysis Set |
-0.31 | <0.0001 sig |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score at Week 52 in the Long-term Effectiveness Analysis Set |
-0.44 | <0.0001 sig |
| SECONDARY Number of Subjects in Each Category of Overall Evaluation in the Effectiveness Analysis Set |
1386; 711; 8 | — |
| SECONDARY Number of Subjects in Each Category of Overall Evaluation in the Long-term Effectiveness Analysis Set |
543; 220; 4; 0 | — |
| SECONDARY Effectiveness Rate in the Effectiveness Analysis Set |
65.84 | — |
| SECONDARY Effectiveness Rate in the Long-term Effectiveness Analysis Set |
70.80 | — |
Eligibility Criteria
Inclusion criteria
- Patients who have been started on Vahelva Respimat in accordance with the approved label in Korea
- Age >= 18 years at enrolment
- Patients who have signed on the data release consent form
Exclusion criteria
- Patients with hypersensitivity to Vahelva Respimat or to any of the excipients.
- Patients with a history of hypersensitivity to atropine or its derivatives(e.g. ipratropium, oxitropium, glycopyrronium, clidinium, umeclidinium)
- Patients with asthma
- Current participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT02864407). 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.