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/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment

Phase 4

Completed

Conditions: COPD

Interventions: Drug: Tiotropium/Formoterol
Drug: Tiotropium
Drug: Formoterol

First Posted Date: 2016-12-09

Last Posted Date: 2020-06-16

Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Target Recruit Count: 84

Registration Number: NCT02988869

Locations: 🇹🇷
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey

Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients

Phase 1

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium
Drug: Olodaterol

First Posted Date: 2016-11-21

Last Posted Date: 2019-03-29

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 12

Registration Number: NCT02969317

Locations: 🇨🇳
West China Hospital, Chengdu, China

Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol
Drug: Glycopyrronium
Drug: Tiotropium
Drug: Placebo
Procedure: photoplethysmography

First Posted Date: 2016-08-18

Last Posted Date: 2021-08-03

Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Target Recruit Count: 42

Registration Number: NCT02872090

Locations: 🇫🇷
Centre Hospitalier Régional Universitaire, Besançon, France

Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium
Drug: Olodaterol

First Posted Date: 2016-08-02

Last Posted Date: 2019-09-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 106

Registration Number: NCT02853123

Locations: 🇧🇪
Hasselt - PRAC Aumann, J-L, Hasselt, Belgium
🇨🇦
McGill University Health Centre (MUHC), Montreal, Quebec, Canada
🇨🇦
McMaster Univ. Medical Centre, Hamilton, Ontario, Canada

and more 10 locations

Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: FDC of tiotropium + olodaterol
Drug: Tiotropium
Drug: Placebo
Drug: Olodaterol

First Posted Date: 2016-02-17

Last Posted Date: 2018-08-17

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 221

Registration Number: NCT02683109

Locations: 🇦🇹
Ordination Dr. Robert Voves, 8330 Feldbach, Feldbach, Austria
🇦🇹
KH d. Elisabethinen Linz, Linz, Austria
🇩🇰
Aarhus Universitetshospital, Aarhus, Denmark

and more 19 locations

Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: tiotropium

First Posted Date: 2016-02-08

Last Posted Date: 2024-12-02

Lead Sponsor: Solventum US LLC

Target Recruit Count: 26

Registration Number: NCT02676297

Locations: 🇬🇧
Quotient Clinical Ltd, Ruddington, Nottingham, United Kingdom

Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: tiotropium
Drug: olodaterol

First Posted Date: 2015-12-15

Last Posted Date: 2019-06-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 184

Registration Number: NCT02629965

Locations: 🇯🇵
Tohno Chuo Clinic, Gifu, Mizunami, Japan
🇯🇵
Kirigaoka Tsuda Hospital, Fukuoka, Kitakyushu, Japan
🇯🇵
Nishi Fukuoka Hospital, Fukuoka, Fukuoka, Japan

and more 40 locations