Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
- Registration Number
- NCT02489981
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 359
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spiriva Spiriva Patients with severe persistent asthma
- Primary Outcome Measures
Name Time Method Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) Week 52 Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Asthma Control Status at Week 52 Baseline and Week 52 The effectiveness was determined based on the change of asthma control status from baseline at Week 52 which is the secondary endpoint in the surveillance. The asthma control status was rated on a 3-point scale of well controlled, insufficiently controlled and poorly controlled based on asthma symptoms (in the daytime or at night), use of reliever and limitation of activities including exercise (based on "Asthma prevention and management guideline").
Well-controlled=WC, Insufficiently-controlled=IC, Poorly-controlled=PC, Unknown=Unk, Missing=Miss, Baseline=BL, Week 52=W52
Trial Locations
- Locations (1)
Hospital Felício Rocho
🇧🇷Belo Horizonte, Brazil