Study Results
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View full resultsBasic Information
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COMPLETED
1899 participants
OBSERVATIONAL
2021-05-14
2021-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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tiotropium + inhaled corticosteroids (ICS) group
tiotropium
tiotropium
inhaled corticosteroids (ICS)
inhaled corticosteroids (ICS)
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group
long-acting β2-agonists (LABA)
long-acting β2-agonists (LABA)
inhaled corticosteroids (ICS)
inhaled corticosteroids (ICS)
Interventions
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tiotropium
tiotropium
long-acting β2-agonists (LABA)
long-acting β2-agonists (LABA)
inhaled corticosteroids (ICS)
inhaled corticosteroids (ICS)
Eligibility Criteria
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Inclusion Criteria
* Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
* Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use
Exclusion Criteria
* Patients less than 12 years of age
* Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
* Patients with prior Tio or ICS/LABA use during the 6-month baseline period
* Patients with urinary bladder obstruction, urinary retention, and glaucoma
* After the propensity score matching (PSM) process, unmatched patients
12 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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eMax Health
White Plains, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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0205-0547
Identifier Type: -
Identifier Source: org_study_id
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