We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02850978
First Posted: August 1, 2016
Last Update Posted: October 16, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with COPD in real-world setting

Condition Intervention
Pulmonary Disease, Chronic Obstructive Drug: Spiolto

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence and exposure-time adjusted incidence rate of adverse drug reactions [ Time Frame: up to 52 weeks ]

Secondary Outcome Measures:
  • COPD assessment test (CAT) at 12 weeks. [ Time Frame: up to 12 weeks ]

Estimated Enrollment: 1300
Actual Study Start Date: August 23, 2016
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spiolto
Patient with COPD to received Spiloto
Drug: Spiolto

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1000
Criteria

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 LABA or 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.
  Contacts and Locations
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): NCT02850978


Locations
Japan
One or Multiple lnvestigational sites, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02850978     History of Changes
Other Study ID Numbers: 1237.34
First Submitted: July 28, 2016
First Posted: August 1, 2016
Last Update Posted: October 16, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes