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OpenTrials
Completed

NCT Number: NCT05501639

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

eMax Health

White Plains, New York, 10601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium

Drug

tiotropium

Long-acting β2-agonists (LABA)

Drug

long-acting β2-agonists (LABA)

Inhaled Corticosteroids (ICs)

Drug

inhaled corticosteroids (ICS)

Primary outcomes

  1. Time to First Severe Exacerbation

    Time frame: From index date to first severe exacerbation, up to 1 year.

    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.

Secondary outcomes

  1. Time to First Moderate-or-severe Exacerbation

    Time frame: From index date to first moderate-or-severe exacerbation, up to 1 year.

    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.

  2. Percentage of Patients With Exacerbation

    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.

  3. Rate of Exacerbation at 6 Months and One Year

    Time frame: at 6 months and one year

    Rate of exacerbation at 6 months and one year is presented.

  4. Percentage of Patients With Health Care Resource Utilization (HCRU)

    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.

  5. Health Care Resource Utilization (HCRU)

    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:

    • 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.
  6. Percentage of Patients With Use of Rescue Medications

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2022
Registry last updated
Apr 1, 2024

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.

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