Long-term Use of Spiolto Respimat in Japanese 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. Read our disclaimer for details. Identifier: NCT02850978
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : December 4, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with COPD in real-world setting

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Spiolto

Study Type : Observational
Actual Enrollment : 1335 participants
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
Actual Study Start Date : August 23, 2016
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Patient with COPD to received Spiloto
Drug: Spiolto

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

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT02850978

Multiple Locations, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT02850978     History of Changes
Other Study ID Numbers: 1237.34
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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