Characteristics of Pts Initiating Spiriva Respimat in Asthma

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

Detailed Description
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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.

Official Title
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Characteristics of Patients Initiating Spiriva Respimat in Asthma in the UK: a Cross-sectional Study Based on the Clinical Practice Research Datalink

Conditions
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Asthma

Intervention / Treatment
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* Device: Spiriva Respimat


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Asthma<br>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<br>* soft-mist inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cardiac Failure | The number of participants who had Cardiac failure 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 |