Specific Use-Result of Spiriva Respimat® in Asthmatics

NCT03188120 | Completed Results

• 1 other identifier: 0205-0536
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  baseline and 12 weeks

Study Arms (1)

Spiriva Respimat group

Drug: Spiriva Respimat

Interventions

Spiriva Respimat DRUG

Drug

Also known as: FORVENT, SPIRIVA, SRIVASSO

Spiriva Respimat group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with mild to moderate persistent bronchial asthma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd

Tokyo, 1416017, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

Patients were not randomized and there are no within-study data. Patients in the study may differ from the overall asthma-treated population, or from treated patients who did not choose to participate in the study.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Yukako Ogi

  zzCDMJP_PV_PMS@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: July 4, 2017
• Primary Completion: September 22, 2018
• Study Completion: November 8, 2018
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

JP (1)