Drug

Tiotropium

Regulatory activity · MHRA

Emerging researchLate-stage development

Also known as Spiriva, Stiolto, Tiotropium Bromide.

RxNorm69120 ChEMBLCHEMBL1900528UNII0EB439235F

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)

Clinical trial2024-12-20Results posted · ClinicalTrials.gov

Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Clinical trial2024-11-07Results expected Q1 2027 · ClinicalTrials.gov

Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients

Clinical trial2024-05-01Withdrawn · ClinicalTrials.gov

Anti-inflammatory Effects of Tiotropium in Patients with Stable COPD- a Multicenter Randomized Controlled Double-blind Study

Clinical trial2023-12-31Completed · ClinicalTrials.gov

A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Clinical trial2023-12-01Completed · ClinicalTrials.gov

A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI

Clinical trial2023-12-01Completed · ClinicalTrials.gov

A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Tiotropium Inhalation Powder (5 μg and 10 μg), Administered as the Bromide Salt From Hard Polyethylene Capsule Via the HandiHaler® 2 and Spiriva® HandiHaler® (18 μg Tiotropium) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical trial2023-12-01Completed · ClinicalTrials.gov

Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study)

Clinical trial2023-12-01Completed · ClinicalTrials.gov

A Randomised, Double-blind Clinical Efficacy and Safety Comparison of Tiotropium/Salmeterol 7.5/25 Inhalation Powder in the Morning Via Tiotropium/Salmeterol HandiHaler, Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler, Salmeterol 50 Mcg MDPI in the Morning and Evening and the Free Combination Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler Plus Salmeterol 50 Mcg MDPI in the Morning and Evening Following Chronic Administration (6-week Treatment Periods) in Patients With COPD

Clinical trial2022-06-28Results posted · ClinicalTrials.gov

Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial.

Research2015-10-01JAMA

Drug Safety Update: Tiotropium

Regulatory2014-12-11MHRA

Tiotropium bromide step-up therapy for adults with uncontrolled asthma.

Research2010-09-19The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Tiotropium

Aliases & brands

SpirivaStioltoTiotropium Bromide

RxNorm CUI

69120

ChEMBL ID

CHEMBL1900528

UNII

0EB439235F

Regulatory jurisdictions

mhra

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Tiotropium

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).