N/A
Completed N=340
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
Source: ClinicalTrials.gov NCT02489981 ↗Enrolled (actual)
340
Serious AEs
2.9%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) — 5.59 Percentage of participants
Summary
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) |
5.59 | — |
| SECONDARY Change From Baseline in Asthma Control Status at Week 52 |
66.67; 58.12; 35.14; 50.00; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion criteria
- Patients diagnosed with severe persistent bronchial asthma
- Patient aged >= 15 years
- Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS (Inhaled corticosteroids) treatment.
Exclusion criteria
- Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
- Patients who have been enrolled this study before.
Data sourced from ClinicalTrials.gov (NCT02489981). 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.