Characteristics of Pts Initiating Spiriva Respimat in Asthma

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

number of subjects with Cardiac arrhythmias[ Time Frame: up to 3 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

number of subjects with Cardiac failure[ Time Frame: up to 3 years ]

Descriptive Information

Brief Title ^ICMJE

Characteristics of Pts Initiating Spiriva Respimat in Asthma

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Device: Spiriva Respimat
soft-mist inhaler

Study Arms

: 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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 31, 2018

Estimated Primary Completion Date

October 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名