Overview

This trial is active, not recruiting.

Condition asthma
Treatment spiriva
Sponsor Boehringer Ingelheim
Start date June 2015
End date August 2017
Trial size 360 participants
Trial identifier NCT02489981, 205.525

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with severe persistent asthma
spiriva
60 puffs

Primary Outcomes

Measure
The primary Outcome is the absolute and relative (%) frequency of patients with suspected adverse drug reactions (ADRs).
time frame: week 52

Secondary Outcomes

Measure
Change from baseline in asthma control status.
time frame: week 52

Eligibility Criteria

Male or female participants at least 15 years old.

Inclusion criteria: - 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. Exclusion criteria: - Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat - Patients who have been enrolled this study before.

Additional Information

Official title Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (Patients With Severe Persistent Asthma)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.