Specific Use-result Surveillance of Spiriva Respimat in Asthmatics

Asthma Clinical Trial

Official title:

Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (Patients With Severe Persistent Asthma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489981
• Other study ID #: 205.525
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: September 28, 2017

Study information

• Verified date: August 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: September 28, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Spiriva
60 puffs

Locations

Country	Name	City	State
Brazil	Hospital Felício Rocho	Belo Horizonte

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Asthma Control Status at Week 52	The effectiveness was determined based on the change of asthma control status from baseline at Week 52 which is the secondary endpoint in the surveillance. The asthma control status was rated on a 3-point scale of well controlled, insufficiently controlled and poorly controlled based on asthma symptoms (in the daytime or at night), use of reliever and limitation of activities including exercise (based on "Asthma prevention and management guideline").; Well-controlled=WC, Insufficiently-controlled=IC, Poorly-controlled=PC, Unknown=Unk, Missing=Miss, Baseline=BL, Week 52=W52	Baseline and Week 52