N/A
Completed N=193
Specific Use-Result of Spiriva Respimat® in Asthmatics
Source: ClinicalTrials.gov NCT03188120 ↗Enrolled (actual)
193
Serious AEs
0.6%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Suspected Adverse Drug Reactions (ADRs) — 5 Participants
Summary
The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Suspected Adverse Drug Reactions (ADRs) |
5 | — |
| SECONDARY The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline |
9; 0; 0; 0; 0; 68 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with mild to moderate 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 treatment.
Exclusion Criteria
- Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
- Patients who have been enrolled in this study before.
Data sourced from ClinicalTrials.gov (NCT03188120). 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.