- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692676
Characteristics of Pts Initiating Spiriva Respimat in Asthma
November 12, 2021 updated by: Boehringer Ingelheim
Characteristics of Patients Initiating Spiriva Respimat in Asthma in the UK: a Cross-sectional Study Based on the Clinical Practice Research Datalink
This study is a cross-sectional, non-interventional study based on existing data (NISed).
Study Overview
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
Observational
Enrollment (Actual)
116133
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ingelheim, Germany
- Boehringer Ingelheim
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Asthmatic 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 from the previous ICS/LABA FDC in the UK during the study period (September, 2014-December 31, 2017)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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soft-mist inhaler
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Cardiac Arrhythmias
Time Frame: On the index date or in the year prior to the index date
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The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date.
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On the index date or in the year prior to the index date
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Cardiac Failure
Time Frame: On the index date or in the year prior to the index date
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The number of participants who had Cardiac failure on the index date or in the year prior to the index date.
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On the index date or in the year prior to the index date
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 5, 2019
Primary Completion (ACTUAL)
October 11, 2019
Study Completion (ACTUAL)
October 11, 2019
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
September 26, 2018
First Posted (ACTUAL)
October 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 12, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- 0205-0537
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
- studies in products where Boehringer Ingelheim is not the license holder;
- studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
- studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datasharing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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