N/A
N=340
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02489981 ↗Enrolled (actual)
340
Serious AEs
2.9%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) — 5.59 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spiriva (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2017
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 | — |
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.
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.