Compare PK & Safety Profiles of 2 Inhalations of Dry Powder Tiotropium
Research type
Research Study
Full title
An Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Compare the Pharmacokinetic Profiles of Tiotropium Bromide Inhalation Powder, Containing 18 mcg Tiotropium with SPIRIVA® HANDIHALER® (18 mcg Tiotropium Powder) Administered in Healthy Subjects under Fasting Conditions.
IRAS ID
223786
Contact name
Brendan Colgan
Contact email
Sponsor organisation
Lupin Inc
Eudract number
2017-000582-76
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 25 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease which is characterized by persistent airflow limitation that is usually progressive and is associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and associated co-morbidities contribute to the overall severity in individual patients and present targets for treatment.
COPD is the 4th leading cause of mortality globally and this is set to increase in prevalence partially in response to historical smoking trends over past decades, although outdoor, occupational and indoor pollutants are also a major risk factor in development of COPD.
The goals of COPD therapy are focused initially on smoking cessation for subjects who continue to smoke followed by relief of symptoms, moderation of exacerbation frequency and severity, and improvement in health quality and exercise tolerance.
Tiotropium bromide is one of a number of long-acting anticholinergic medications approved for use with COPD.The anticholinergic medications work by blocking the effect of acetylcholine on muscarinic receptors which results in smooth muscle relaxation and bronchodilation, which opens the airways and lowers airway resistance.
Tiotropium has been shown to reduce exacerbations and related hospitalization, improve health status and increase the effectiveness of pulmonary rehabilitation, in addition to providing a maintenance therapy for bronchospasm.
Lupin Inc. is developing a tiotropium bromide dry powder inhaler (DPI) as a substitutable product for SPIRIVA HANDIHALER.REC name
HSC REC A
REC reference
17/NI/0030
Date of REC Opinion
10 Mar 2017
REC opinion
Further Information Favourable Opinion