N/A
Completed N=7,857
Impact of Tiotropium Add-on Therapy in Patients With Asthma
Source: ClinicalTrials.gov NCT03964220 ↗Enrolled (actual)
7,857
Serious AEs
—
Results posted
Oct 2020
Primary outcomePrimary: Time to First Exacerbation — 340.656; 123.151 Days — p=0.044
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Exacerbation |
340.656; 123.151 | 0.044 sig |
| SECONDARY Rate of Exacerbation at 6 Months and 1 Year of Follow-up |
41.40; 116.07; 15.65; 57.24 | < 0.0001 sig |
| SECONDARY Health Care Resource Utilization (HCRU) During Follow-up |
23.97; 46.51; 4.89; 20.27; 45.00; 84.67 | — |
| SECONDARY Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period |
77.77; 85.69 | — |
| SECONDARY Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period |
15.65; 16.16 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03964220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.