Clinical trial NCT02864407: Vahelva Respimat Regulatory Post-marketing Surveillance in Korean Patients With Chronic Obstructive Pulmonary Disease
Official title: A Regulatory Required Non Interventional Study to Monitor the Safety and Effectiveness of Once Daily Treatment of Orally Inhaled Vahelva Respimat (Tiotropium + Olodaterol Fixed Dose Combination 2.5µg/2.5µg Per Puff (2 Puffs Comprise One Medicinal Dose)) for Korean Patients With COPD (Chronic Obstructive Pulmonary Disease)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 3223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with COPD

Brief summary: To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with COPD in a routine clinical practice setting

Detailed description: Study Design:

regulatory PMS study

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

Primary outcomes:
measure: Percentage of Subjects With Any Adverse Event, Unexpected Adverse Event, Unexpected Serious Adverse Event, Adverse Event Leading to Discontinuation
timeFrame: From the signing date on Informed Consent Form (ICF) to 28 days after last administration date of Vahelva® Respimat®, up to 52 (±2) weeks+ 28 days.
measure: 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
timeFrame: From the signing date on Informed Consent Form (ICF) to 28 days after last administration date of Vahelva® Respimat®, up to 52 (±2) weeks+ 28 days.
measure: Percentage of Subjects With Any Adverse Event (AE) in the Long-term Safety Analysis Set
timeFrame: From the signing date on Informed Consent Form (ICF) to 28 days after last administration date of Vahelva® Respimat®, up to 52 (±2) weeks+ 28 days.
measure: Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24 in the Effectiveness Analysis Set
timeFrame: At baseline (30 days before baseline visit (Visit 1)) and Week 24 (±2 weeks).
measure: Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 52 in the Effectiveness Analysis Set
timeFrame: At baseline (30 days before baseline visit (Visit 1)) and Week 52 (±2 weeks).
measure: 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
timeFrame: At baseline (30 days before baseline visit (Visit 1)) and Week 24 (±2 weeks).
measure: 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
timeFrame: At baseline (30 days before baseline visit (Visit 1)) and Week 52 (±2 weeks).
Secondary outcomes:
measure: Change From Baseline in Post Bronchodilator Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24 in the Effectiveness Analysis Set
timeFrame: At baseline and Week 24 (±2 weeks).
measure: Change From Baseline in Post Bronchodilator Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 52 in the Effectiveness Analysis Set
timeFrame: At baseline and Week 52 (±2 weeks).
measure: 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
timeFrame: At baseline and Week 24 (±2 weeks).
measure: 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
timeFrame: At baseline and Week 52 (±2 weeks).
measure: Transition Dyspnea Index (TDI) Focal Score at Week 24 in the Effectiveness Analysis Set
timeFrame: At Week 24 (±2 weeks).
measure: Transition Dyspnea Index (TDI) Focal Score at Week 52 in the Effectiveness Analysis Set
timeFrame: At Week 52 (±2 weeks).
measure: Transition Dyspnea Index (TDI) Focal Score at Week 24 in the Long-term Effectiveness Analysis Set
timeFrame: At Week 24 (±2 weeks).
measure: Transition Dyspnea Index (TDI) Focal Score at Week 52 in the Long-term Effectiveness Analysis Set
timeFrame: At Week 52 (±2 weeks).
measure: Number of Subjects in Each Category of Overall Evaluation in the Effectiveness Analysis Set
timeFrame: At baseline and at Week 24 (±2 weeks) or at Week 52 (±2 weeks).
measure: Number of Subjects in Each Category of Overall Evaluation in the Long-term Effectiveness Analysis Set
timeFrame: At baseline and at Week 24 (±2 weeks) or at Week 52 (±2 weeks).
measure: Effectiveness Rate in the Effectiveness Analysis Set
timeFrame: At baseline and at Week 24 (±2 weeks) or at Week 52 (±2 weeks).
measure: Effectiveness Rate in the Long-term Effectiveness Analysis Set
timeFrame: At baseline and at Week 24 (±2 weeks) or at Week 52 (±2 weeks).
Other outcomes:
Locations:
city: One Or Multiple Sites
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: