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

Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Phase 4

Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-11-01

Last Posted Date: 2009-12-17

Lead Sponsor: Otsuka Pharmaceutical, Inc., Philippines

Target Recruit Count: 50

Registration Number: NCT00394485

Locations: 🇵🇭
Philippine General Hospital, Manila, National Capital Region, Philippines

Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-10-17

Last Posted Date: 2023-12-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 327

Registration Number: NCT00388882

Locations: 🇺🇸
205.346.105 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States
🇦🇷
205.346.509, Rosario, Santa Fe, Argentina
🇦🇷
205.346.511, Rosario, Santa Fé, Argentina

and more 37 locations

Tiotropium / Respimat One Year Study in COPD.

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Device: Respimat
Drug: Tiotropium

First Posted Date: 2006-10-12

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 3991

Registration Number: NCT00387088

Locations: 🇺🇸
205.372.01028 Boehringer Ingelheim Investigational Site, Rancho Mirage, California, United States
🇺🇸
205.372.01060 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States
🇺🇸
205.372.01008 Boehringer Ingelheim Investigational Site, Norwalk, Connecticut, United States

and more 331 locations

An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

Phase 2

Completed

Conditions: Asthma

First Posted Date: 2006-08-17

Last Posted Date: 2013-07-11

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 115

Registration Number: NCT00365560

Locations: 🇳🇱
lokatie het Spittaal, Zutphen, Netherlands
🇳🇱
Polikliniek longziekten, Hengelo, Netherlands
🇩🇪
Boehringer Ingelheim Investigational Site, Wiesloch, Germany

and more 2 locations

A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-08-02

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 349

Registration Number: NCT00359788

Locations: 🇺🇸
205.325.935 Boehringer Ingelheim Investigational Site, Fort Collins, Colorado, United States
🇺🇸
205.325.917 Boehringer Ingelheim Investigational Site, Buffalo, New York, United States
🇺🇸
205.325.924 Boehringer Ingelheim Investigational Site, East Orange, New Jersey, United States

and more 28 locations

Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-01-25

Last Posted Date: 2013-11-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 76

Registration Number: NCT00281567

Locations: 🇳🇱
Boehringer Ingelheim Investigational Site, Study chairs or principal investigators, Netherlands

Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease

Phase 1

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: GSK233705
Drug: Tiotropium
Drug: Placebo

First Posted Date: 2006-01-19

Last Posted Date: 2017-09-25

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 31

Registration Number: NCT00279019

Locations: 🇩🇪
GSK Investigational Site, Berlin, Germany

A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-01-11

Last Posted Date: 2013-11-05

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 36

Registration Number: NCT00274534

Locations: 🇺🇸
Hunter Holmes McGuire Medical Center, Richmond, Virginia, United States
🇺🇸
Hines Veterans Administration Hospital, Hines, Illinois, United States

Tiotropium (Spiriva) Rehabilitation Study

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-01-11

Last Posted Date: 2013-11-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 108

Registration Number: NCT00274521

Locations: 🇺🇸
Harbor-UCLA Research and Education Institute, Torrance, California, United States
🇺🇸
St. Francis Hospital and Medical Center, Hartford, Connecticut, United States
🇺🇸
Temple University Hospital, Philadelphia, Pennsylvania, United States

and more 9 locations

Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

First Posted Date: 2006-01-11

Last Posted Date: 2013-11-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1829

Registration Number: NCT00274547

Locations: 🇺🇸
Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States
🇺🇸
Hampton VA Medical Center, Hampton, Virginia, United States
🇺🇸
Carl T. Hayden VA Medical Center, Phoenix, Arizona, United States

and more 10 locations

Drug Development Updates

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