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

Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug

Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Device: Spiriva® Respimat®
Device: Spiriva® HandiHaler®
Drug: Tiotropium bromide

First Posted Date: 2022-05-05

Last Posted Date: 2025-02-26

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 9

Registration Number: NCT05362487

Locations: 🇨🇭
Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal, Liestal, Switzerland

Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease

Not Applicable

Recruiting

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Tiotropium Bromide Combined With Odaterol

First Posted Date: 2022-03-25

Last Posted Date: 2022-10-21

Lead Sponsor: Guangzhou Institute of Respiratory Disease

Target Recruit Count: 72

Registration Number: NCT05295355

Locations: 🇨🇳
Guangzhou Institute of Respiratory Diseases, Guangzhou, Guangdong, China

Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Tiotropium Bromide Monohydrate

First Posted Date: 2022-02-18

Last Posted Date: 2022-08-18

Lead Sponsor: Orion Corporation, Orion Pharma

Target Recruit Count: 88

Registration Number: NCT05246046

Locations: 🇫🇮
Clinical Pharmacology Unit, Orion Corporation, Espoo, Finland

Replication of the INSPIRE Trial in Healthcare Claims Data

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: salmeterol-fluticasone
Drug: Tiotropium

First Posted Date: 2022-01-05

Last Posted Date: 2023-07-27

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 98278

Registration Number: NCT05179512

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Device: Stiolto Respimat
Device: Trelegy Ellipta
Drug: Tiotropium + Olodaterol (5/5 mcg)
Drug: Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)

First Posted Date: 2021-12-27

Last Posted Date: 2023-10-19

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 9117

Registration Number: NCT05169424

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

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Revefenacin
Drug: Tiotropium
Drug: Revefenacin Placebo
Drug: Tiotropium Placebo

First Posted Date: 2021-12-21

Last Posted Date: 2024-12-20

Lead Sponsor: Theravance Biopharma

Target Recruit Count: 404

Registration Number: NCT05165485

Locations: 🇺🇸
Theravance Biopharma Investigational Site site 2, Clearwater, Florida, United States
🇺🇸
Theravance Biopharma Investigational Site, Cudahy, Wisconsin, United States
🇺🇸
Theravance Biopharma Investigational Site #2, Spartanburg, South Carolina, United States