Specific Use-Result of Spiriva Respimat® in Asthmatics

Completed

• Conditions: Asthma
• Interventions: Drug: Spiriva Respimat

• Registration Number: NCT03188120
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-15
• Study Start: 2017-07-04
• Primary Completion: 2018-09-22
• Study Completion: 2018-11-08
• Status Verified: 2019-11
• Results First Submitted: 2019-11-08
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spiriva Respimat group	Spiriva Respimat	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Suspected Adverse Drug Reactions (ADRs)	From first drug administration until 30 days after last drug administration; up to 337 days	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.

Secondary Outcome Measures

Name	Time	Method
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline	baseline and 12 weeks	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).

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd; 🇯🇵 Tokyo, Japan