eMax Health
White Plains, New York, 10601, United States
NCT Number: NCT05501639
The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.
Looking for future studies?
Notify Me12 year and older
All sexes
Observational
White Plains, New York, 10601, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tiotropium
long-acting β2-agonists (LABA)
inhaled corticosteroids (ICS)
Time frame: From index date to first severe exacerbation, up to 1 year.
Severe exacerbation defined as:
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
Time frame: From index date to first moderate-or-severe exacerbation, up to 1 year.
Severe exacerbation defined as:
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
Time frame: From index date through first report of exacerbation, up to 1 year.
Percentage of patients with exacerbation is presented. Design 2: The second analysis, included on an ad-hoc basis was using an intent-to-treat (ITT) design where patients were assigned to the cohort, they were part of at the index date.
Time frame: at 6 months and one year
Rate of exacerbation at 6 months and one year is presented.
Time frame: From index date to end of follow-up, up to 1 year.
Percentage of patients with Health care resource utilization (HCRU) is presented and is defined as hospitalizations, emergency room (ER) visits, and outpatient visits during follow-up, all-cause and asthma related.
Time frame: From index date to end of follow-up, up to 1 year.
Health care resource utilization (HCRU) are presented including frequency of hospitalizations, ER visits, outpatient visits. Outpatient visits are defined as clinic, hospital, or other medical institution (e.g. public health, etc.) visit as an outpatient.
Mean and standard deviations of:
Time frame: From index date to end of follow-up, up to 1 year.
Percentage of patients with use of rescue medications is presented. Use of rescue medication is defined as patients with one or more short-acting β2-agonists (SABA) claims during the follow-up period.
Boehringer Ingelheim
Industry
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.
Published trials that share one or more normalized conditions with this study.
NCT07394127
Asthma, Asthma Chronic
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye)
View Trial DetailsNCT01678222
Allergic Inflammation, Asthma
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT03937804
Asthma, Bronchial Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial Details