Specific Use-Result of Spiriva Respimat® in Asthmatics

Boehringer Ingelheim193 enrolled

Overview

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

The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Study Type

OBSERVATIONAL

Enrollment

193

Conditions

Asthma

Interventions

Spiriva RespimatDRUG

Drug

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Suspected Adverse Drug Reactions (ADRs)

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

Secondary Outcomes

The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline

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

Data from ClinicalTrials.gov

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