AsthmaNCT05501639
Exacerbation Risk in Asthma
An observational study of Asthma, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS. 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, long-acting β2-agonists (LABA) and inhaled corticosteroids (ICS)
- How many people
- 1,899 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 2 Nov 2021
- 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: Patients with least two asthma diagnosis will be included. Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use.
Who may be able to join
- Patients with least two asthma diagnosis
- Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
- Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use
Who cannot join
- Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
- Patients less than 12 years of age
- Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
- Patients with prior Tio or ICS/LABA use during the 6-month baseline period
- Patients with urinary bladder obstruction, urinary retention, and glaucoma
- After the propensity score matching (PSM) process, unmatched patients
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.
- Conditions
- Asthma
- Being tested
- tiotropium, long-acting β2-agonists (LABA), inhaled corticosteroids (ICS)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropiumDrug
tiotropium
long-acting β2-agonists (LABA)Drug
long-acting β2-agonists (LABA)
inhaled corticosteroids (ICS)Drug
inhaled corticosteroids (ICS)
| Study group | Role | What they receive |
|---|---|---|
| tiotropium + inhaled corticosteroids (ICS) group | Not described Receives: Drug: tiotropium; Drug: inhaled corticosteroids (ICS) | |
| long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group | Not described Receives: Drug: long-acting β2-agonists (LABA); Drug: inhaled corticosteroids (ICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Severe Exacerbation
Severe exacerbation defined as:
- Hospitalization with primary diagnosis of asthma or
- Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations).
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
Measured: From index date to first severe exacerbation, up to 1 year.
Secondary outcomes (6)
Time to First Moderate-or-severe Exacerbation
Severe exacerbation defined as:
- Hospitalization with primary diagnosis of asthma or
- Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations).
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
Measured: From index date to first moderate-or-severe exacerbation, up to 1 year.
Percentage of Patients With Exacerbation
Percentage of patients with exacerbation is presented. Design 2: The second analysis, included on an ad-hoc basis was using an intent-to-treat (ITT) design where patients were assigned to the cohort, they were part of at the index date.
Measured: From index date through first report of exacerbation, up to 1 year.
Rate of Exacerbation at 6 Months and One Year
Rate of exacerbation at 6 months and one year is presented.
Measured: at 6 months and one year
Percentage of Patients With Health Care Resource Utilization (HCRU)
Percentage of patients with Health care resource utilization (HCRU) is presented and is defined as hospitalizations, emergency room (ER) visits, and outpatient visits during follow-up, all-cause and asthma related.
Measured: From index date to end of follow-up, up to 1 year.
Health Care Resource Utilization (HCRU)
Health care resource utilization (HCRU) are presented including frequency of hospitalizations, ER visits, outpatient visits. Outpatient visits are defined as clinic, hospital, or other medical institution (e.g. public health, etc.) visit as an outpatient.
Mean and standard deviations of:
- Number of hospitalisations per person per month
- Number of asthma-related hospitalisations per person per month
- Number of ER visits per person per month
- Number of asthma-related ER visits per person per month
- Number of outpatient visits per person per month
- Number of asthma-related outpatient visits per person per month are presented.
Measured: From index date to end of follow-up, up to 1 year.
Percentage of Patients With Use of Rescue Medications
Percentage of patients with use of rescue medications is presented. Use of rescue medication is defined as patients with one or more short-acting β2-agonists (SABA) claims during the follow-up period.
Measured: From index date to end of follow-up, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start14 May 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
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
- 1,899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501639
- Sponsor's protocol ID
- 0205-0547
- Status last verified
- Oct 2023
- First submitted
- 12 Aug 2022
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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. Exceptions might apply, e.g. 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 (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbation Risk in Asthma
- ClinicalTrials.gov ID
- NCT05501639
- Acronym / sponsor ID
- 0205-0547
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,899 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium + inhaled corticosteroids (ICS) group | – | Drug: tiotropium, Drug: inhaled corticosteroids (ICS) |
| long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group | – | Drug: long-acting β2-agonists (LABA), Drug: inhaled corticosteroids (ICS) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with least two asthma diagnosis will be included. Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use.
Key inclusion criteria (3 listed)
- Patients with least two asthma diagnosis
- Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
- Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use
Key exclusion criteria (6 listed)
- Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
- Patients less than 12 years of age
- Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
- Patients with prior Tio or ICS/LABA use during the 6-month baseline period
- Patients with urinary bladder obstruction, urinary retention, and glaucoma
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 |
|---|---|---|
| tiotropiumtiotropium | Drug | tiotropium + inhaled corticosteroids (ICS) group |
| long-acting β2-agonists (LABA)long-acting β2-agonists (LABA) | Drug | long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group |
| inhaled corticosteroids (ICS)inhaled corticosteroids (ICS) | Drug | long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group, tiotropium + inhaled corticosteroids (ICS) group |
Primary outcome
Time to First Severe Exacerbation
Time frame: From index date to first severe exacerbation, up to 1 year.
Severe exacerbation defined as: * Hospitalization with primary diagnosis of asthma or * Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations). Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
6 secondary outcomes
Time to First Moderate-or-severe Exacerbation
Time frame: From index date to first moderate-or-severe exacerbation, up to 1 year.
Percentage of Patients With Exacerbation
Time frame: From index date through first report of exacerbation, up to 1 year.
Rate of Exacerbation at 6 Months and One Year
Time frame: at 6 months and one year
Percentage of Patients With Health Care Resource Utilization (HCRU)
Time frame: From index date to end of follow-up, up to 1 year.
Health Care Resource Utilization (HCRU)
Time frame: From index date to end of follow-up, up to 1 year.
Percentage of Patients With Use of Rescue Medications
Time frame: From index date to end of follow-up, up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- 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. Exceptions might apply, e.g. 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 (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Related trials for Asthma
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
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 6 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 1 Apr 2024. 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 1 Apr 2024). 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 Severe Exacerbation (time frame: From index date to first severe exacerbation, up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.