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Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

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: NCT04184297
Recruitment Status : Completed
First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium and Olodaterol (Tio+Olo) Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)

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Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects initiated with Tiotropium and Olodaterol (Tio+Olo) Drug: Tiotropium and Olodaterol (Tio+Olo)
drug

Subjets initiated with LABA/LAMA/ICS
Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods
Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
drug




Primary Outcome Measures :
  1. Time to the first COPD exacerbation occurrence of a hospitalization for COPD (severe exacerbation) or ED visit [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Time to First hospitalization for community-acquired pneumonia (serious pneumonia) based on ICD-9-CM diagnoses [ Time Frame: Up to 6 years ]


Information from the National Library of Medicine

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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
Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA
Criteria

Inclusion Criteria:

  • New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
  • Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date

Exclusion Criteria:

  • Less than one year of medical history information prior to the date of combined treatment initiation (index date)
  • Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
  • Asthma diagnosis within one year prior to the index date

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): NCT04184297


Locations
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United States, Massachusetts
HealthCore, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04184297    
Other Study ID Numbers: 1237-0094
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
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.boehringer-ingelheim.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'.
URL: https://trials.boehringer‐ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Olodaterol
Muscarinic Antagonists
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