AsthmaNCT03964220

Impact of Tiotropium Add-on Therapy in Patients With Asthma

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

Completed

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

Trial summary

To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Tiotropium Respimat® and Inhaled Corticosteroid/Long-acting beta-agonist
How many people: 7,857 participants
Where: 1 siteUnited States
Study dates: 15 Mar 2019to 20 Sep 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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)

Who may be able to join

Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
Patients will be required to have available records 12 months prior to the index date.

Who cannot join

Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
Patients with a diagnosis of COPD at any time during the study period will be excluded.
Those who are on biologics at baseline will be removed.
After the PSM process, unmatched patients will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

eMax Health
White Plains, New York, 10601

Other trials in United States

About this study

Official title: The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma

To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy

Conditions: Asthma
Being tested: Tiotropium Respimat®, Inhaled Corticosteroid/Long-acting beta-agonist
Medical subject headings: Asthma

What participants receive

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

Tiotropium Respimat®Drug
Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )
Inhaled Corticosteroid/Long-acting beta-agonistDrug
baseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA

Study groups in NCT03964220
Study group	Role	What they receive
Patients with Asthma		Not described Receives: Drug: Tiotropium Respimat®; Drug: Inhaled Corticosteroid/Long-acting beta-agonist

What is being measured

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

Time to First Exacerbation
Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded.
Measured: From baseline until end of follow-up, up to 3 years

Secondary outcomes (4)

Rate of Exacerbation at 6 Months and 1 Year of Follow-up
Exacerbation rate per 100 person-years. Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group).
Measured: At 6 month and 1 year of follow-up
Health Care Resource Utilization (HCRU) During Follow-up
Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period.
Measured: During follow-up period, From baseline until end of follow-up, up to 3 years
Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period
Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. FEV1 score range from 0 to 100. Higher FEV1 score suggests normal lung function, while lower for dangerous. Only the descriptive statistics of FEV1 score were reported other than change of FEV1 score from baseline due to lack of enough data points.
Measured: From baseline until end of follow-up, up to 3 years
Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period
Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. Only the descriptive statistics of ACT score were reported other than change of ACT score from baseline due to lack of enough data points.
Measured: From baseline until end of follow-up, up to 3 years

Timeline

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

15 Mar 201920 Sep 2019

First posted28 May 2019
Study start15 Mar 2019
Primary completion20 Sep 2019
Study completion20 Sep 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: Retrospective
Enrolment: 7,857 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03964220
Sponsor's protocol ID: 0205-0543
Status last verified: Oct 2020
First submitted: 24 May 2019
Last updated: 3 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial\_results/ clinical\_submission\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

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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RecruitingPhase 2
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma
ClinicalTrials.gov ID: NCT03964220
Acronym / sponsor ID: 0205-0543
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 7,857 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Mar 2019 (actual)
Primary completion: 20 Sep 2019 (actual)
Study completion: 20 Sep 2019 (actual)
First posted: 28 May 2019 (actual)
Results: Posted 12 Oct 2020

Clinical summary

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

To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with Asthma	–	Drug: Tiotropium Respimat®, Drug: Inhaled Corticosteroid/Long-acting beta-agonist

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)

Key inclusion criteria (3 listed)

Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
Patients will be required to have available records 12 months prior to the index date.

Key exclusion criteria (4 listed)

Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
Patients with a diagnosis of COPD at any time during the study period will be excluded.
Those who are on biologics at baseline will be removed.
After the PSM process, unmatched patients will be excluded.

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
Tiotropium Respimat®Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )	Drug	Patients with Asthma
Inhaled Corticosteroid/Long-acting beta-agonistbaseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA	Drug	Patients with Asthma

Primary outcome

Time to First Exacerbation
Time frame: From baseline until end of follow-up, up to 3 years
Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded.

4 secondary outcomes

Rate of Exacerbation at 6 Months and 1 Year of Follow-up
Time frame: At 6 month and 1 year of follow-up
Health Care Resource Utilization (HCRU) During Follow-up
Time frame: During follow-up period, From baseline until end of follow-up, up to 3 years
Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period
Time frame: From baseline until end of follow-up, up to 3 years
Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period
Time frame: From baseline until end of follow-up, up to 3 years

Results and safety

Results posted to the registry on 12 Oct 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
Tiotropium Respimat® (Tio Group)	2,619	2,619
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	5,238	5,238

Primary outcome: Time to First Exacerbation

Time frame: From baseline until end of follow-up, up to 3 years. Mean (Standard Deviation). Unit: Days

Measure	Tiotropium Respimat® (Tio Group) n = 2619	Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) n = 5238
Value	340.656 (428.061)	123.151 (152.600)

Tiotropium Respimat® (Tio Group) vs Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group): Hazard Ratio (HR): 0.65 (95% CI 0.427 to 0.990), p = 0.044, Regression, Cox

Population analysed: This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium Respimat® (Tio Group)	0 of 0	0 of 0	0
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
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
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
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Community Acquired Pneumonia (CAP)
RecruitingPhase 2
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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 United States.

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 3 inclusion and 4 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 3 Nov 2020. 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 United States. 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 12 Oct 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?

Time to First Exacerbation (time frame: From baseline until end of follow-up, up to 3 years). 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 NCT03964220.

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 3 Nov 2020.