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

Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease

Completed

Conditions: Glaucoma, Angle-Closure
Chronic Obstructive Pulmonary Disease

Interventions: Drug: Tiotropium

First Posted Date: 2024-07-29

Last Posted Date: 2024-07-29

Lead Sponsor: Giresun University

Target Recruit Count: 108

Registration Number: NCT06525051

Locations: 🇹🇷
Giresun Training and Research Hospital, Giresun, Gi̇resun, Turkey

ANTES B+ Clinical Trial

Phase 4

Recruiting

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Drug: Brimica
Drug: Duaklir
Drug: Ultibro
Drug: Ulunar
Drug: Xoterna
Drug: Anoro
Drug: Laventair
Drug: Spiolto Respimat
Drug: Yanimo
Drug: Foradil
Drug: Broncoral
Drug: Formoterol stada
Drug: Oxis
Drug: Formatris
Drug: Formoterol Aldo
Drug: Onbrez
Drug: Oslif
Drug: Hirobriz
Drug: Striverdi
Drug: Beglan
Drug: Betamican
Drug: Inaspir
Drug: Serevent
Drug: Soltel
Drug: Eklira
Drug: Bretaris
Drug: Seebri
Drug: Tovanor
Drug: Enurev
Drug: Spiriva
Drug: Tavulus
Drug: Sirkava
Drug: Braltus
Drug: Gregal
Drug: Incruse
Drug: Rolufta

First Posted Date: 2024-02-28

Last Posted Date: 2024-03-05

Lead Sponsor: Fundacio Privada Mon Clinic Barcelona

Target Recruit Count: 1028

Registration Number: NCT06282861

Locations: 🇪🇸
Hospital Clínic Barcelona, Barcelona, Catalunya, Spain

Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure

Phase 4

Completed

Conditions: COPD

Interventions: Drug: Indacaterol
Drug: Tiotropium

First Posted Date: 2022-08-18

Last Posted Date: 2022-08-18

Lead Sponsor: National Institute of Respiratory Diseases, Mexico

Target Recruit Count: 97

Registration Number: NCT05506865

Locations: 🇲🇽
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas", Mexico, City, Mexico

Exacerbation Risk in Asthma

Completed

Conditions: Asthma

Interventions: Drug: long-acting β2-agonists (LABA)
Drug: tiotropium
Drug: inhaled corticosteroids (ICS)

First Posted Date: 2022-08-15

Last Posted Date: 2024-04-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1899

Registration Number: NCT05501639

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

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

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

Replication of the POET-COPD Trial in Healthcare Claims Data

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Salmeterol
Drug: Tiotropium

First Posted Date: 2021-10-19

Last Posted Date: 2023-07-27

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 8716

Registration Number: NCT05083429

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

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

Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

Phase 1

Completed

Conditions: Healthy Volunteer Study

Interventions: Drug: Tiotropium

First Posted Date: 2019-05-10

Last Posted Date: 2019-09-23

Lead Sponsor: Orion Corporation, Orion Pharma

Target Recruit Count: 20

Registration Number: NCT03945344

Locations: 🇫🇮
Clinical Pharmacology Unit, Espoo, Finland

A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: budesonide/formoterol
Drug: albuterol/salbutamol
Drug: FF/UMEC/VI
Drug: Placebo to match budesonide/formoterol
Drug: Placebo to match FF/UMEC/VI
Drug: tiotropium
Drug: placebo to match tiotropium
Device: ELLIPTA
Device: MDI
Device: HandiHaler

First Posted Date: 2018-03-27

Last Posted Date: 2020-10-28

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 729

Registration Number: NCT03478683

Locations: 🇳🇱
GSK Investigational Site, Zutphen, Netherlands

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