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Vahelva Respimat Regulatory Post-marketing Surveillance in Korean Patients With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02864407
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Vahelva Respimat(Tiotropium + Olodaterol)

Detailed Description:

Study Design:

regulatory PMS study


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : December 19, 2016
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Vahelva group
Korean patients with COPD who are newly prescribed with Vahelva Respimat
Drug: Vahelva Respimat(Tiotropium + Olodaterol)
2.5 microgram and 2.5 microgram 2 puffs comprise one medicinal dose




Primary Outcome Measures :
  1. Change from baseline in (pre-dose) FEV1 [ Time Frame: Up to 26 Weeks ]

Secondary Outcome Measures :
  1. BDI (Baseline Dyspnea Index) [ Time Frame: up to 24 weeks ]
  2. TDI (Transition Dyspnea Index) [ Time Frame: up to 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean patients with COPD
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864407


Contacts
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Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Korea, Republic of
Chonnam National University Hospital Recruiting
One Or Multiple Sites, Korea, Republic of, 61469
Contact: Yu Il Kim    82-10-2249-4232    kyionly@jnu.ac.kr   
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02864407     History of Changes
Other Study ID Numbers: 1237.60
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action