Exacerbation Risk in Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: tiotropium; Drug: inhaled corticosteroids (ICS); Drug: long-acting β2-agonists (LABA)

• Study Type: Observational
• Enrollment (Actual): 1899

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10601
      • eMax Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with least two asthma diagnosis will be included. Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
tiotropium + inhaled corticosteroids (ICS) group	Drug: tiotropium; tiotropium; Drug: inhaled corticosteroids (ICS); inhaled corticosteroids (ICS)
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group	Drug: inhaled corticosteroids (ICS); inhaled corticosteroids (ICS); Drug: long-acting β2-agonists (LABA); long-acting β2-agonists (LABA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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
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.
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.
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 β2-agonists (SABA) claims during the follow-up period.	From index date to end of follow-up, up to 1 year.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 0205-0547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• 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