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.
Study Type
OBSERVATIONAL
Enrollment
359
60 puffs
Hospital Felício Rocho
Belo Horizonte, Brazil
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
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.
Time frame: Week 52
Change From Baseline in Asthma Control Status at 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
Time frame: Baseline and Week 52
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