Characteristics of Pts Initiating Spiriva Respimat in Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692676
• Other study ID #: 0205-0537
• Status: Completed
• Start date: March 5, 2019
• Est. completion date: October 11, 2019

Study information

• Verified date: November 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116133
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Spiriva Respimat
soft-mist inhaler

Locations

Country	Name	City	State
Germany	Boehringer Ingelheim	Ingelheim

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Related Info