Exacerbation Risk in Asthma

Asthma Clinical Trial

Official title:

Exacerbation Risk in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501639
• Other study ID #: 0205-0547
• Status: Completed
• Start date: May 14, 2021
• Est. completion date: November 2, 2021

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1899
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients with least two asthma diagnosis

• 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 with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• tiotropium
tiotropium
• long-acting ß2-agonists (LABA)
long-acting ß2-agonists (LABA)
• inhaled corticosteroids (ICS)
inhaled corticosteroids (ICS)

Locations

Country	Name	City	State
United States	eMax Health	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Severe Exacerbation	Severe exacerbation defined as: Hospitalization with primary diagnosis of asthma or; Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations).; 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.	From index date to first severe exacerbation, up to 1 year.
Secondary	Time to First Moderate-or-severe Exacerbation	Severe exacerbation defined as: Hospitalization with primary diagnosis of asthma or; Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations).; 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.	From index date to first moderate-or-severe exacerbation, up to 1 year.
Secondary	Percentage of Patients With Exacerbation	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.	From index date through first report of exacerbation, up to 1 year.
Secondary	Rate of Exacerbation at 6 Months and One Year	Rate of exacerbation at 6 months and one year is presented.	at 6 months and one year
Secondary	Percentage of Patients With Health Care Resource Utilization (HCRU)	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.	From index date to end of follow-up, up to 1 year.
Secondary	Health Care Resource Utilization (HCRU)	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: Number of hospitalisations per person per month; Number of asthma-related hospitalisations per person per month; Number of ER visits per person per month; Number of asthma-related ER visits per person per month; Number of outpatient visits per person per month; Number of asthma-related outpatient visits per person per month are presented.	From index date to end of follow-up, up to 1 year.
Secondary	Percentage of Patients With Use of Rescue Medications	Percentage of patients with use of rescue medications is presented. Use of rescue medication is defined as patients with one or more short-acting ß2-agonists (SABA) claims during the follow-up period.	From index date to end of follow-up, up to 1 year.

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