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Completed

NCT Number: NCT03692676

Characteristics of Pts Initiating Spiriva Respimat in Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim

Ingelheim, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spiriva Respimat

Device

soft-mist inhaler

Primary outcomes

  1. Number of Participants With Cardiac Arrhythmias

    Time frame: 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 outcomes

  1. Number of Participants With Cardiac Failure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2018
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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