NCT03964220 is a clinical trial of Tiotropium Respimat® in Asthma, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03964220?

NCT03964220 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03964220?

Interventions in NCT03964220: Tiotropium Respimat®, Inhaled Corticosteroid/Long-acting beta-agonist.

Is NCT03964220 still recruiting?

NCT03964220 is currently completed. Last updated 3 November 2020.

Are results published for NCT03964220?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-03 · How we verify

NCT03964220

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Tiotropium Add-on Therapy in Patients With Asthma

Completed Results posted Last updated 3 November 2020

What this trial tests

trial testing Tiotropium Respimat® in Asthma in 7,857 participants. Completed in 20 September 2019.

Timeline

15 March 2019

Primary endpoint
20 September 2019

20 September 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	7,857
Start date	15 March 2019
Primary completion	20 September 2019
Estimated completion	20 September 2019
Sites	1 location across United States

Drugs / interventions tested

Tiotropium Respimat® — full drug profile →
Inhaled Corticosteroid/Long-acting beta-agonist — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to First Exacerbation Primary · 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.

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	340.656	± 428.061
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	123.151	± 152.600

Rate of Exacerbation at 6 Months and 1 Year of Follow-up Secondary · At 6 month 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).

At 6 months of follow-up

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	41.40
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	116.07

At 1 year of follow-up

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	15.65
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	57.24

Health Care Resource Utilization (HCRU) During Follow-up Secondary · During follow-up period, From baseline until end of follow-up, up to 3 years

Hospitalization (all cause)

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	23.97
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	46.51

Hospitalization (asthma related)

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	4.89
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	20.27

Emergency room (ER) visit (all cause)

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	45.00
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	84.67

ER visit (asthma related)

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	12.23
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	47.70

Outpatient (OP) visit (all cause)

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	206.92
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	232.55

OP visit (asthma related)

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	133.06
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	158.61

Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period Secondary · From baseline until end of follow-up, up to 3 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) 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.

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	77.77	± 20.16
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	85.69	± 20.77

Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period Secondary · From baseline until end of follow-up, up to 3 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) 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

Group	Value	95% CI
Tiotropium Respimat® (Tio Group)	15.65	± 7.0
Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group)	16.16	± 5.3

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Packaging and Delivery of Asthma Therapeutics.
Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03964220 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 3 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03964220.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing