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

Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium bromide + Olodaterol
Device: Sp(t)iolto® Respimat®

First Posted Date: 2021-06-15

Last Posted Date: 2021-11-15

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1371146

Registration Number: NCT04926233

Locations: 🇺🇸
AETION inc, New York, New York, United States

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Tiotropium Bromide Monohydrate
Drug: Tiotropium Easyhaler with oral activated charcoal

First Posted Date: 2021-04-20

Last Posted Date: 2021-10-25

Lead Sponsor: Orion Corporation, Orion Pharma

Target Recruit Count: 43

Registration Number: NCT04850144

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

Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

Phase 2

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Tiotropium bromide inhalation solution
Drug: Placebo

First Posted Date: 2021-03-04

Last Posted Date: 2021-05-10

Lead Sponsor: Nephron Pharmaceuticals Corporation

Target Recruit Count: 116

Registration Number: NCT04780984

Locations: 🇺🇸
Clinical Research of Rock Hill, Rock Hill, South Carolina, United States

Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium bromide plus Olodaterol

First Posted Date: 2020-12-17

Last Posted Date: 2024-06-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1396

Registration Number: NCT04672941

Locations: 🇬🇷
Metropolitan Hospitsal, PNOI Pulmonology Clinic, Athens, Greece
🇬🇷
European Interbalkan Medical Center, Pulmonology Clinic, Thessaloniki, Greece

Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses

Phase 4

Completed

Conditions: Allergic Asthma

Interventions: Drug: tiotropium bromide monohydrate (Spiriva Respimat)
Drug: matching placebo

First Posted Date: 2020-12-02

Last Posted Date: 2021-09-30

Lead Sponsor: University of Saskatchewan

Target Recruit Count: 15

Registration Number: NCT04648813

Locations: 🇨🇦
Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall, Saskatoon, Saskatchewan, Canada

Three Treatment of Chronic Obstructive Pulmonary Disease Patients

Phase 4

Completed

Conditions: COPD

Interventions: Drug: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid
Drug: Tiotropium 18 mcg capsule inhaled once daily + Budesonide
Drug: Formoterol/Tiotropium

First Posted Date: 2020-08-20

Last Posted Date: 2020-08-20

Lead Sponsor: Tanta University

Target Recruit Count: 45

Registration Number: NCT04520230

Early Intervention Efficacy in COPD

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium/Olodaterol
Drug: Tiotropium

First Posted Date: 2020-01-30

Last Posted Date: 2022-06-14

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 6788

Registration Number: NCT04249310

Locations: 🇯🇵
Nara Medical University, Nara, Japan

A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium + olodaterol
Drug: Placebo

First Posted Date: 2020-01-10

Last Posted Date: 2021-11-18

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 213

Registration Number: NCT04223843

Locations: 🇺🇸
Meris Clinical Research, Brandon, Florida, United States
🇺🇸
Clinical Research Specialists LLC, Kissimmee, Florida, United States
🇩🇪
Klinische Forschung Berlin GbR, Berlin, Germany

and more 22 locations