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

Associated Therapies: -

Clinical Trials

The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Early Phase 1

Completed

Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis

Interventions: Drug: Tiotropium

First Posted Date: 2009-03-27

Last Posted Date: 2014-10-01

Lead Sponsor: ThomasTruncale

Target Recruit Count: 5

Registration Number: NCT00870896

Locations: 🇺🇸
University of South Florida (COPH), Tampa, Florida, United States
🇺🇸
James A Haley Veterans' Hospital, Tampa, Florida, United States

Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: tiotropium with fluticasone propionate/salmeterol (FSC)
Drug: tiotropium

First Posted Date: 2009-03-19

Last Posted Date: 2010-03-31

Lead Sponsor: The Korean Academy of Tuberculosis and Respiratory Diseases

Target Recruit Count: 509

Registration Number: NCT00864812

Locations: 🇰🇷
Kyunghee university medical center, Seoul, Korea, Republic of
🇰🇷
Inje university Pusan Paik hospital, Busan, Korea, Republic of
🇰🇷
Soonchunhyang University Bucheon Hospital, Bucheon, Korea, Republic of

and more 29 locations

Exacerbation Study

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol 150 µg
Drug: Tiotropium

First Posted Date: 2009-02-18

Last Posted Date: 2013-11-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 3439

Registration Number: NCT00845728

Locations: 🇻🇪
Novartis Investigative Site, Maracaibo, Estado Zulia, Venezuela

Tiotropium and Salmeterol PK Study in COPD Patients

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2008-05-07

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 50

Registration Number: NCT00673478

Locations: 🇧🇪
1184.24.32001 Boehringer Ingelheim Investigational Site, Genk, Belgium
🇧🇪
1184.24.32002 Boehringer Ingelheim Investigational Site, Hasselt, Belgium
🇳🇱
1184.24.31001 Boehringer Ingelheim Investigational Site, Heerlen, Netherlands

Tiotropium/Salmeterol Inhalation Powder in COPD

Phase 3

Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium/Salmeterol
Drug: Tiotropium
Drug: Salmeterol
Drug: Tiotropium/Salmeterol QD + Salmeterol
Drug: Placebo

First Posted Date: 2008-04-29

Last Posted Date: 2023-11-07

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 207

Registration Number: NCT00668772

Locations: 🇱🇻
1184.15.37153 Boehringer Ingelheim Investigational Site, Tukums, Latvia
🇺🇸
1184.15.01071 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States
🇩🇰
1184.15.45054 Boehringer Ingelheim Investigational Site, Aalborg, Denmark

and more 61 locations

Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium

First Posted Date: 2008-02-27

Last Posted Date: 2014-03-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 2031

Registration Number: NCT00624377

Locations: 🇨🇳
Boehringer Ingelheim Investigational Site 1, Taipiei, Taiwan
🇨🇳
Boehringer Ingelheim Investigational Site 5, Taipiei, Taiwan
🇨🇳
Boehringer Ingelheim Investigational Site, Taoyuan, Taiwan

and more 4 locations

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Indacaterol
Drug: Tiotropium
Drug: Placebo

First Posted Date: 2008-02-14

Last Posted Date: 2011-08-17

Lead Sponsor: Novartis

Target Recruit Count: 169

Registration Number: NCT00615459

Locations: 🇪🇸
Novartis Investigator Site, Orense, Spain
🇪🇸
Novartis Investigative Site, Madrid, Spain
🇪🇸
Novartis Investigative site, Alicante, Spain

and more 1 locations