Exacerbation Risk in Asthma

Boehringer Ingelheim

Status: Completed

Conditions: Asthma

Treatments: Drug: inhaled corticosteroids (ICS); Drug: long-acting β2-agonists (LABA); Drug: tiotropium

Study type: Observational

Funder types: Industry

Identifiers

NCT05501639

0205-0547

Details and patient eligibility

About

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.

Enrollment: 1,899 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,899 participants in 2 patient groups

tiotropium + inhaled corticosteroids (ICS) group

Treatment:

Drug: inhaled corticosteroids (ICS)

Drug: tiotropium

long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group

Treatment:

Drug: inhaled corticosteroids (ICS)

Drug: long-acting β2-agonists (LABA)