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

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: BDP/FF/GB
Drug: BDP/FF + Tiotropium
Drug: Tiotropium

First Posted Date: 2013-07-30

Last Posted Date: 2021-10-29

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Target Recruit Count: 3686

Registration Number: NCT01911364

Locations: 🇮🇹
Azienda Ospedaliera Perugia, Perugia, Italy
🇩🇪
Institut für klinische Forschung, Hessen, Germany
🇭🇺
Csongrád Megyei Mellkasi Betegségek Szakkórháza, Szeged, Hungary

Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Indacaterol
Drug: Tiotropium

First Posted Date: 2012-11-15

Last Posted Date: 2017-01-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 140

Registration Number: NCT01727024

Locations: 🇧🇷
Novartis Investigative Site, São Paulo, SP, Brazil

Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

Phase 4

Withdrawn

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Placebo to tiotropium
Drug: Indacaterol
Drug: Placebo to indacaterol
Drug: Tiotropium

First Posted Date: 2012-10-26

Last Posted Date: 2017-04-20

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01715311

A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Phase 2

Terminated

Conditions: Chronic Obstructive Pulmonary Disease
COPD

Interventions: Drug: AZD8683
Drug: Placebo
Drug: Tiotropium

First Posted Date: 2012-10-16

Last Posted Date: 2014-01-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 3

Registration Number: NCT01708057

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium
Drug: Placebo matching Olodaterol
Drug: Olodaterol

First Posted Date: 2012-09-28

Last Posted Date: 2014-11-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1137

Registration Number: NCT01696058

Locations: 🇺🇸
1222.52.02068 Boehringer Ingelheim Investigational Site, Chesterfield, Missouri, United States
🇺🇸
1222.52.02035 Boehringer Ingelheim Investigational Site, Henderson, Nevada, United States
🇺🇸
1222.52.02091 Boehringer Ingelheim Investigational Site, Syracuse, New York, United States

and more 91 locations

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Olodaterol
Drug: Placebo matching Olodaterol
Drug: Tiotropium

First Posted Date: 2012-09-27

Last Posted Date: 2014-09-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1134

Registration Number: NCT01694771

Locations: 🇺🇸
1222.51.01079 Boehringer Ingelheim Investigational Site, Tamarac, Florida, United States
🇺🇸
1222.51.01076 Boehringer Ingelheim Investigational Site, Austell, Georgia, United States
🇺🇸
1222.51.01041 Boehringer Ingelheim Investigational Site, San Diego, California, United States

and more 87 locations