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OpenTrials
Completed

NCT Number: NCT02850978

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spiolto

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2016
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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