Specific Use-result Surveillance of Spiriva Respimat in Asthmatics

NCT02489981 | Completed Results

• 1 other identifier: 205.525
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)

  Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.

  Week 52

Secondary Outcomes (1)

• Change From Baseline in Asthma Control Status at Week 52

  Baseline and Week 52

Study Arms (1)

Spiriva

Patients with severe persistent asthma

Drug: Spiriva

Interventions

Spiriva DRUG

60 puffs

Spiriva

Eligibility Criteria

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

Study Population

patients with severe asthma

You may qualify if:

• Patients diagnosed with severe 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 (Inhaled corticosteroids) 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 this study before.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Hospital Felício Rocho

Belo Horizonte, 30110-060, Brazil

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 Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: September 28, 2017
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-08

Locations

BR (1)