Specific Use-Result of Spiriva Respimat® in Asthmatics

Asthma Clinical Trial

Official title:

Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188120
• Other study ID #: 0205-0536
• Status: Completed
• Start date: July 4, 2017
• Est. completion date: November 8, 2018

Study information

• Verified date: November 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: November 8, 2018
• Est. primary completion date: September 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Spiriva Respimat
Drug

Locations

Country	Name	City	State
Japan	Nippon Boehringer Ingelheim Co., Ltd	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first drug administration until 30 days after last drug administration; up to 337 days
Secondary	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).	baseline and 12 weeks

External Links

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