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A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment

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.
 
ClinicalTrials.gov Identifier: NCT04011475
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to collect the data on Chronic Obstructive Pulmonary Disease (COPD) patients who were administered with Long-Acting Beta-Agonist/ Long-Acting Muscarinic Antagonist (LABA/LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium + Olodaterol Drug: Other LABA/LAMA Drug: LAMA

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Study Type : Observational
Actual Enrollment : 1617 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease
Actual Study Start Date : December 29, 2019
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Subjects with Tiotropium and Olodaterol Drug: Tiotropium + Olodaterol
Spiolto®

Subjects treated with other LABA/LAMA therapy Drug: Other LABA/LAMA
tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium

Subjects treated with LAMA therapy Drug: LAMA
aclidinium bromide, glycopyrronium, tiotropium, umeclidinium




Primary Outcome Measures :
  1. Time to the first moderate or severe COPD exacerbation [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Annualized rate of mild/moderate/severe exacerbation [ Time Frame: Up to 3 years ]
  2. Time to (e.g., severe airflow limitation, diagnosis of asthma, worsening exacerbation) from LABA/LAMA escalating to LABA/LAMA/ICS or from LAMA to dual therapy [ Time Frame: Up to 3 years ]
  3. Number of reasons (e.g., severe airflow limitation, diagnosis of asthma, worsening exacerbation) from LABA/LAMA escalating to LABA/LAMA/ICS or from LAMA to dual therapy [ Time Frame: Up to 3 years ]
  4. Percentage of patients receiving LABA/LAMA switched to triple therapy or LAMA switched to dual therapy [ Time Frame: Up to 3 years ]
  5. Change from baseline in pulmonary function after LABA/LAMA or LAMA initiation will be evaluated by COPD Assessment Test (CAT) [ Time Frame: Up to 3 years ]
  6. Percentage of patients with use of rescue medications [ Time Frame: Up to 3 years ]
  7. Change from baseline in pulmonary function after LABA/LAMA or LAMA initiation will be evaluated bymodified Medical Research Council dyspnea scale (mMRC) [ Time Frame: Up to 3 years ]
    mMRC is a 4-item questionnaire for measuring the severity of dyspnea of patients. If mMRC scale of the patient is > 2, it means the patient may suffer from dyspnea.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The data will be retrospectively abstracted from the medical chart after eligibility assessment. Eligible patients will be categorized into the cohort A (patients treated with Tio + Olo), B (patients treated with other LABA/LAMA therapy), and C (patients treated with LAMA therapy).
Criteria

Inclusion Criteria:

Patients who fulfil ALL the following criteria are included.

  1. Patients who diagnosed with COPD who were prescribed with LABA/LABA (FDC or free combo) as a new initiation or switching from other therapy (i.e., single/dual/triple), or newly receiving LAMA treatment for 3 months at least prior to 30 June 2018
  2. Male or female patients ≥ 40 years of age

Exclusion Criteria:

1. Patients who meet the following criterion are not included.

  • Patients with documented diagnosis of bronchial asthma, asthma-COPD overlap syndrome (ACOS), bronchiectasis, cystic fibrosis, or lung cancer

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): NCT04011475


Locations
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Taiwan
Ditmanson Medical Foundation Chia - Yi Christian Hospital
Chia YI City, Taiwan, 600
CGMH Chia YI
Chia YI City, Taiwan, 613
Eda hospital
Kaohsiung City, Taiwan, 824
CGMH Kaohsiung
Kaohsiung City, Taiwan, 833
Far east memorial hospital
New Taipei City, Taiwan, 220
China medicine memorial hospital
Taichung City, Taiwan, 404
VGH Taichung
Taichung City, Taiwan, 407
National Taiwan University hospital
Taipei City, Taiwan, 100
Makay memorial hospital
Taipei City, Taiwan, 104
Cheng Hsin general hospital
Taipei City, Taiwan, 112
Taipei Tzu Chi hospital
Taipei City, Taiwan, 231
CGMH Linkou
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04011475    
Other Study ID Numbers: 1237-0086
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action