Characteristics of Pts Initiating Spiriva Respimat in Asthma

Completed

• Conditions: Asthma
• Interventions: Device: Spiriva Respimat

• Registration Number: NCT03692676
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

The UK CPRD data will be used to assess the characteristics of asthma 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 in the UK during the study period (September 2014-December 2017) enabling to assess potential channeling of prescribing to different patient populations.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-10-02
• Study Start: 2019-03-05
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Results First Submitted: 2020-10-08
• Results First Submitted QC: 2020-12-18
• Results First Posted: 2020-12-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116133

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Asthma	Spiriva Respimat	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cardiac Arrhythmias	On the index date or in the year prior to the index date	The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cardiac Failure	On the index date or in the year prior to the index date	The number of participants who had Cardiac failure on the index date or in the year prior to the index date.

Trial Locations

Locations (1)

Boehringer Ingelheim; 🇩🇪 Ingelheim, Germany