N/A
N=193
Specific Use-Result of Spiriva Respimat® in Asthmatics
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03188120 ↗Enrolled (actual)
193
Serious AEs
0.6%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Suspected Adverse Drug Reactions (ADRs) — 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spiriva Respimat (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2018
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 | — |
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
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.