Impact of Tiotropium Add-on Therapy in Patients With Asthma

Asthma Clinical Trial

Official title:

The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964220
• Other study ID #: 0205-0543
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: October 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7857
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.

• Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).

• Patients will be required to have available records 12 months prior to the index date.

Exclusion Criteria:

• Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.

• Patients with a diagnosis of COPD at any time during the study period will be excluded.

• Those who are on biologics at baseline will be removed.

• After the PSM process, unmatched patients will be excluded.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Tiotropium Respimat®
Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )
• Inhaled Corticosteroid/Long-acting beta-agonist
baseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA

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 Exacerbation	Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded.	From baseline until end of follow-up, up to 3 years
Secondary	Rate of Exacerbation at 6 Months and 1 Year of Follow-up	Exacerbation rate per 100 person-years. Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group).	At 6 month and 1 year of follow-up
Secondary	Health Care Resource Utilization (HCRU) During Follow-up	Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period.	During follow-up period, From baseline until end of follow-up, up to 3 years
Secondary	Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period	Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. FEV1 score range from 0 to 100. Higher FEV1 score suggests normal lung function, while lower for dangerous. Only the descriptive statistics of FEV1 score were reported other than change of FEV1 score from baseline due to lack of enough data points.	From baseline until end of follow-up, up to 3 years
Secondary	Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period	Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. Only the descriptive statistics of ACT score were reported other than change of ACT score from baseline due to lack of enough data points.	From baseline until end of follow-up, up to 3 years

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