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Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS

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: NCT04138758
Recruitment Status : Completed
First Posted : October 24, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation.

Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.


Condition or disease Intervention/treatment
COPD Drug: Tiotropium bromide + Olodaterol Drug: LABA/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 and Long-acting β2 Agonists 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
All participants Drug: Tiotropium bromide + Olodaterol
Tiotropium bromide + Olodaterol

Drug: LABA/ICS
Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)




Primary Outcome Measures :
  1. time to first COPD exacerbation after cohort entry [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Tme to first hospitalization for community-acquired pneumonia [ Time Frame: Up to 6 years ]
  2. Time to a pharmacy dispensing indicating escalation to triple therapy [ Time Frame: Up to 6 years ]
  3. Time to an adverse outcome [ Time Frame: Up to 6 years ]
    exacerbation, hospitalization for pneumonia, and escalation to triple therapy, defined as time from cohort entry until the earliest primary or secondary outcome



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:

  1. At least one prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March 2019.

    1. The first dispensing of either Tio+Olo or LABA/ICS combined inhaler will be defined as the index date.
    2. For the main analyses, only fixed dose combination (FDC) inhalers will be included. Sensitivity analyses will also accept free combinations of LABA/ICS.
  2. At least one diagnosis of COPD at any time prior to the index date.
  3. At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.

Exclusion Criteria:

  1. To increase the likelihood of a true diagnosis of COPD, we will exclude:

    1. All patients less than 40 years of age on the index date, and
    2. All patients with a diagnosis of asthma in the year prior to the index date
  2. To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
  3. To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least 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): NCT04138758


Locations
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United States, Massachusetts
HealthCore, Inc.
Watertown, Massachusetts, United States, 02472
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04138758    
Other Study ID Numbers: 1237-0093
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: November 27, 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bromides
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
Anticonvulsants