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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02850978
First received: July 28, 2016
Last updated: July 20, 2017
Last verified: July 2017
  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: 1200
Actual Study Start Date: August 23, 2016
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: July 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spiolto
Patient with COPD to received Spiloto
Drug: Spiolto

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02850978

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

Locations
Japan
Recruiting
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
Study First Received: July 28, 2016
Last Updated: July 20, 2017

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

ClinicalTrials.gov processed this record on August 22, 2017