Tiotropium

Generic Name: Tiotropium

Brand Names: Inspiolto Respimat, Spiriva, Spiriva Respimat, Stiolto

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₂NO_₄S_₂

CAS Number: 186691-13-4

Unique Ingredient Identifier: 0EB439235F

Background: Tiotropium is a long-acting, antimuscarinic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD) and asthma. Tiotropium acts mainly on M3 muscarinic receptors located in the airways to produce smooth muscle relaxation and bronchodilation.

Tiotropium is more specific for the subset of muscarinic receptors commonly found in the lungs than ipratropium.

Tiotropium was granted FDA approval on 30 January 2004.

Indication: Tiotropium powder for inhalation is indicated for the maintenance of bronchospasm in COPD and to prevent exacerbations of COPD. A combination tiotropium and olodaterol metered inhalation spray is indicated for maintenance of COPD. A tiotropium inhalation spray is indicated for the maintenance of bronchospasm in COPD, to prevent exacerbations of COPD, and to treat asthma in patients 12 or more years old. A tiotropium metered inhalation spray is indicated for the maintenance of bronchospasm in COPD, to prevent exacerbations of COPD, and to treat asthma in patients 6 or more years old.

Associated Conditions: Asthma, Bronchitis, Bronchoconstriction, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Exacerbation of COPD

Clinical Trials

Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Activity of Beta-receptors in Healthy Volunteers

Not Applicable

Conditions: Health, Subjective
Hyperreactivity, Bronchial

Interventions: Drug: Formoterol
Drug: Tiotropium Bromide
Diagnostic Test: metacholine test

First Posted Date: 2019-10-23

Last Posted Date: 2019-10-23

Lead Sponsor: Federal State Budgetary Institution, Pulmonology Scientific Research Institute

Target Recruit Count: 20

Registration Number: NCT04137029

Locations: 🇷🇺
Kirill Zykov, Moscow, Russian Federation

Anti-inflammatory Effects of Tiotropium in Patients With Stable COPD

Phase 4

Conditions: COPD

Interventions: Drug: Tiotropium Bromide

First Posted Date: 2019-08-19

Last Posted Date: 2022-07-20

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 50

Registration Number: NCT04061161

Locations: 🇳🇱
University Medical Center, Groningen, Netherlands
🇳🇱
Medical centrum Leeuwarden, Leeuwarden, Netherlands

A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium + Olodaterol
Drug: Other LABA/LAMA
Drug: LAMA

First Posted Date: 2019-07-08

Last Posted Date: 2022-06-14

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1617

Registration Number: NCT04011475

Locations: 🇨🇳
Ditmanson Medical Foundation Chia - Yi Christian Hospital, Chia YI City, Taiwan
🇨🇳
CGMH Chia YI, Chia YI City, Taiwan
🇨🇳
CGMH Kaohsiung, Kaohsiung City, Taiwan

and more 9 locations

Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD

Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Bufei Yishen granule
Drug: Placebo Bufei Yishen granule
Drug: Tiotropium Bromide Powder for Inhalation

First Posted Date: 2019-06-06

Last Posted Date: 2019-06-06

Lead Sponsor: Henan University of Traditional Chinese Medicine

Target Recruit Count: 348

Registration Number: NCT03976713

Locations: 🇨🇳
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China

A Study on Whether Patients Prefer the Spiriva® Respimat® or the Spiriva® Handihaler® for Treating Their Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium Respimat® (T1)
Drug: Tiotropium Handihaler® (T2)

First Posted Date: 2019-05-28

Last Posted Date: 2023-10-13

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 72

Registration Number: NCT03964207

Locations: 🇨🇳
First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
🇨🇳
Zhongshan Hospital Fudan University, Shanghai, China
🇨🇳
The First Hospital of China Medical University, Shenyang, China

and more 5 locations

Impact of Tiotropium Add-on Therapy in Patients With Asthma

Completed

Conditions: Asthma

Interventions: Drug: Tiotropium Respimat®
Drug: Inhaled Corticosteroid/Long-acting beta-agonist

First Posted Date: 2019-05-28

Last Posted Date: 2020-11-03

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 7857

Registration Number: NCT03964220

Locations: 🇺🇸
eMax Health, White Plains, New York, United States

Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

Phase 1

Completed

Conditions: Healthy Volunteer Study

Interventions: Drug: Tiotropium

First Posted Date: 2019-05-10

Last Posted Date: 2019-09-23

Lead Sponsor: Orion Corporation, Orion Pharma

Target Recruit Count: 20

Registration Number: NCT03945344

Locations: 🇫🇮
Clinical Pharmacology Unit, Espoo, Finland

Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography

Not Applicable

Recruiting

Conditions: Airway Remodeling

Interventions: Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg
Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

First Posted Date: 2019-02-15

Last Posted Date: 2022-09-29

Lead Sponsor: Guangzhou Institute of Respiratory Disease

Target Recruit Count: 100

Registration Number: NCT03842839

Locations: 🇨🇳
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Effect of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD

Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Salbutamol (Ventolin®)
Drug: Tiotropium Bromide (Spiriva®)
Drug: Salmeterol / fluticasone (Seretide®)
Drug: YCC capsule
Drug: BL capsule

First Posted Date: 2018-11-19

Last Posted Date: 2018-11-19

Lead Sponsor: Henan University of Traditional Chinese Medicine

Target Recruit Count: 240

Registration Number: NCT03745261

Locations: 🇨🇳
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China

A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: budesonide/formoterol
Drug: albuterol/salbutamol
Drug: FF/UMEC/VI
Drug: Placebo to match budesonide/formoterol
Drug: Placebo to match FF/UMEC/VI
Drug: tiotropium
Drug: placebo to match tiotropium
Device: ELLIPTA
Device: MDI
Device: HandiHaler

First Posted Date: 2018-03-27

Last Posted Date: 2020-10-28

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 732

Registration Number: NCT03478696

Locations: 🇩🇪
GSK Investigational Site, Leipzig, Germany

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