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OpenTrials
Completed

NCT Number: NCT03188120

Specific Use-Result of Spiriva Respimat® in Asthmatics

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd

Tokyo, 1416017, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spiriva Respimat

Drug

Drug

Other names: FORVENT, SPIRIVA, SRIVASSO

Primary outcomes

  1. Number of Participants With Suspected Adverse Drug Reactions (ADRs)

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2017
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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