AsthmaNCT03692676

Characteristics of Pts Initiating Spiriva Respimat in Asthma

An observational study of Asthma, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Spiriva Respimat
Type of treatment: Medical device
How many people: 116,133 participants
Where: 1 siteGermany
Study dates: 5 Mar 2019to 11 Oct 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Boehringer Ingelheim
Ingelheim

Other trials in Germany

About this study

Official title: 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).

Read the 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.

Conditions: Asthma
Being tested: Spiriva Respimat
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spiriva RespimatDevice
soft-mist inhaler

Study groups in NCT03692676
Study group	Role	What they receive
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 Receives: Device: Spiriva Respimat

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: On the index date or in the year prior to the index date

Secondary outcomes (1)

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.
Measured: On the index date or in the year prior to the index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 201911 Oct 2019

First posted2 Oct 2018
Study start5 Mar 2019
Primary completion11 Oct 2019
Study completion11 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 116,133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03692676
Sponsor's protocol ID: 0205-0537
Status last verified: Apr 2025
First submitted: 25 Sep 2018
Last updated: 17 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: 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: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characteristics of Patients Initiating Spiriva Respimat in Asthma in the UK: a Cross-sectional Study Based on the Clinical Practice Research Datalink
ClinicalTrials.gov ID: NCT03692676
Acronym / sponsor ID: 0205-0537
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 116,133 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 5 Mar 2019 (actual)
Primary completion: 11 Oct 2019 (actual)
Study completion: 11 Oct 2019 (actual)
First posted: 2 Oct 2018 (actual)
Results: Posted 21 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Subjects with Asthma	–	Device: Spiriva RespimatAsthmatic 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spiriva Respimatsoft-mist inhaler	Device	Subjects with Asthma

Primary outcome

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.

1 secondary outcome

Number of Participants With Cardiac Failure
Time frame: On the index date or in the year prior to the index date

Results and safety

Results posted to the registry on 21 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiriva Respimat	10,365	940
Leukotriene Receptor Antagonist (LTRA)	51,142	3,704
ICS/LABA Fixed Dose Combination (Switchers)	49,479	11,135
ICS Dose Increase of ICS/LABA Fixed Dose Combination User	5,147	1,561

Primary outcome: Number of Participants With Cardiac Arrhythmias

Time frame: On the index date or in the year prior to the index date. Count of participants. Unit: Participants

Measure	Spiriva Respimat n = 940	Leukotriene Receptor Antagonist (LTRA) n = 3704	ICS/LABA Fixed Dose Combination (Switchers) n = 11135	ICS Dose Increase of ICS/LABA Fixed Dose Combination User n = 1561
Value	11	17	102	16

Population analysed: Asthma patients who initiated Spiriva Respimat, who initiated leukotriene receptor antagonist (LTRA), who received a higher dose of ICS/LABA FDC, or who switched to a new ICS/LABA FDC in asthma, and who did not violate any of the exclusion criteria, in the United Kingdom during the studied period (Sep 2014 - Dec 2017).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: In this non-interventional study based on existing data, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Spiriva Respimat	0 of 0	0 of 0
Leukotriene Receptor Antagonist (LTRA)	0 of 0	0 of 0
ICS/LABA Fixed Dose Combination (Switchers)	0 of 0	0 of 0
ICS Dose Increase of ICS/LABA Fixed Dose Combination User	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. 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

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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Cardiac Arrhythmias (time frame: On the index date or in the year prior to the index date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03692676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.