Specific Use-Result of Spiriva Respimat® in Asthmatics

Number of participants with suspected adverse drug reactions (ADRs) is presented. An Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.

Time frame: From first drug administration until 30 days after last drug administration; up to 337 days

Population: Safety set

The change from baseline in asthma control status at week 12 using Asthma prevention and management guideline is presented. Well controlled is a better outcome compared to Insufficiently controlled and Poorly controlled outcomes. Abbreviations used: Baseline (BL), Week 12 (W12), Well-controlled (WC), Insufficiently controlled (IC), Poorly controlled (PC), Unknown (UNK), Missing (MIS); If a patient was well-controlled at baseline and maintained the state until Week 12, the effectiveness was assessed as no change. If a patient insufficiently controlled or poorly controlled at baseline became well-controlled at Week 12, or if a patient was poorly controlled at baseline and became insufficiently controlled at Week 12, Spiriva Respimat was assessed as effective (or the patient assessed as a responder). If the disease condition did not improve in a patient at Week 12 from baseline, Spiriva Respimat was assessed as ineffective (or the patient assessed as a non-responder).

Time frame: baseline and 12 weeks

Population: Effectiveness set that excluded patients who were not associated with effectiveness data available (pulmonary function test or laboratory values related to asthma control status) as defined at baseline and/or on treatment.