Characteristics of Pts Initiating Spiriva Respimat in Asthma

NCT03692676 | Completed Results FDA Device

• 1 other identifier: 0205-0537
• Study Type: observational
• Target: 116,133
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a cross-sectional, non-interventional study based on existing data (NISed).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Cardiac Arrhythmias

  The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date.

  On the index date or in the year prior to the index date

Secondary Outcomes (1)

• Number of Participants With Cardiac Failure

  On the index date or in the year prior to the index date

Study Arms (1)

Subjects with Asthma

Asthmatic patients prescribed Inhaled corticosteroids/Long-acting beta agonists (ICS/LABA FDC) before index date, initiated with Spiriva Respimat, or received a higher dose of ICS/LABA FDC, initiated LTRA , or switched to a new ICS/LABA FDC fom the previous ICS/LABA FDC

Device: Spiriva Respimat

Interventions

Spiriva Respimat DEVICE

soft-mist inhaler

Subjects with Asthma

Eligibility Criteria

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

Study Population

Asthmatic patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC from the previous ICS/LABA FDC in the UK during the study period (September, 2014-December 31, 2017)

You may qualify if:

• Aged 18 years and above at the index date
• At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Database (CPRD)
• Had a diagnosis of asthma before the index date
• Being treated with Inhaled corticosteroids/Long-acting beta agonists (ICS LABA FDC) before the index date (at least one prescription within 3 months before the index date)
• Patients who were new users of Spiriva Respimat, or LTRA, or patients who were prescribed a higher dose of ICS/LABA FDC, or patients who switched to a new ICS/LABA FDC from the previous ICS/LABA FDC

You may not qualify if:

• Patients who were prescribed other Long-acting muscarinic antagonists (LAMA) any time before or on the index date
• In the primary analysis, patients who were diagnosed with COPD before or on the index date will be excluded from the study. In a sensitivity analysis, patients who had both asthma and COPD diagnoses will be included in the study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim

Ingelheim, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 2, 2018
• Study Start: March 5, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: April 17, 2025
• Results First Posted: December 21, 2020

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)