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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
Results First Posted : December 6, 2019
Last Update Posted : December 6, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting

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

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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 Spiolto
Drug: Spiolto

Primary Outcome Measures :
  1. Percentage of Participants With Adverse Drug Reactions [ Time Frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. ]
    Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".

Secondary Outcome Measures :
  1. Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
    The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions.

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 Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (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

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Multiple Locations, Japan
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Statistical Analysis Plan  [PDF] November 29, 2018
Study Protocol  [PDF] May 10, 2016

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02850978    
Other Study ID Numbers: 1237.34
First Posted: August 1, 2016    Key Record Dates
Results First Posted: December 6, 2019
Last Update Posted: December 6, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases