Characteristics of Pts Initiating Spiriva Respimat in Asthma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-05

Study Completion Date

2019-10-11

Brief Summary

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

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Spiriva Respimat

Intervention Type DEVICE

soft-mist inhaler

Interventions

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Spiriva Respimat

soft-mist inhaler

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No