Clinical trial • Phase III • Respiratory
Tiotropium bromide for Chronic obstructive pulmonary disease
Phase III trial of Tiotropium bromide for Chronic obstructive pulmonary disease. open-label, none/not specified-controlled. 75 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Chronic obstructive pulmonary disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-05-2025
- First CTIS Authorization Date
- 16-09-2025
Trial design
open-label, none/not specified-controlled Phase III trial across 11 sites in Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 75
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 3
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 75
Spain
- Earliest CTIS Part Ii Submission Date
- 01-07-2025
- Latest Decision Or Authorization Date
- 16-09-2025
- Processing Time Days
- 77
- Number Of Sites
- 11
- Number Of Participants
- 75
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Neumologia
- Principal Investigator Name
- Carlos Antonio Amado
- Principal Investigator Email
- carlosantonio.amado@scsalud.es
- Contact Person Name
- Carlos Antonio Amado
- Contact Person Email
- carlosantonio.amado@scsalud.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Neumologia
- Principal Investigator Name
- Juan Fernández Lahera
- Principal Investigator Email
- jfzlahera@yahoo.es
- Contact Person Name
- Juan Fernández Lahera
- Contact Person Email
- jfzlahera@yahoo.es
- Site Name
- Hospital Universitario Torrecardenas
- Department Name
- Neumologia
- Principal Investigator Name
- Belén Navas Bueno
- Principal Investigator Email
- belnabu@hotmail.com
- Contact Person Name
- Belén Navas Bueno
- Contact Person Email
- belnabu@hotmail.com
- Site Name
- Clinica Sagrada Familia
- Department Name
- Neumologia
- Principal Investigator Name
- Arturo Huerta Garcia
- Principal Investigator Email
- ahuerta@clinicasagradafamilia.com
- Contact Person Name
- Arturo Huerta Garcia
- Contact Person Email
- ahuerta@clinicasagradafamilia.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neumologia
- Principal Investigator Name
- Agustín Valido Morales
- Principal Investigator Email
- asvmtino@gmail.com
- Contact Person Name
- Agustín Valido Morales
- Contact Person Email
- asvmtino@gmail.com
- Site Name
- Consorci Mar Parc De Salut De Barcelona
- Department Name
- Neumologia
- Principal Investigator Name
- Sergi Pascual Guardia
- Principal Investigator Email
- spascual@psmar.cat
- Contact Person Name
- Sergi Pascual Guardia
- Contact Person Email
- spascual@psmar.cat
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Neumologia
- Principal Investigator Name
- Jose Ignacio Madruga Martin
- Principal Investigator Email
- imadruga@saludcastillayleon.es
- Contact Person Name
- Jose Ignacio Madruga Martin
- Contact Person Email
- imadruga@saludcastillayleon.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Neumologia
- Principal Investigator Name
- María Salud Santos Pérez
- Principal Investigator Email
- saludsantos@bellvitgehospital.cat
- Contact Person Name
- María Salud Santos Pérez
- Contact Person Email
- saludsantos@bellvitgehospital.cat
- Site Name
- Centro de Salud Ensanche de Vallecas
- Department Name
- Neumologia
- Principal Investigator Name
- Luis Fernandez Pacheco
- Principal Investigator Email
- luisfernandezpacheco@gmail.com
- Contact Person Name
- Luis Fernandez Pacheco
- Contact Person Email
- luisfernandezpacheco@gmail.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Neumologia
- Principal Investigator Name
- Elena Rodríguez Jimeno
- Principal Investigator Email
- elena.rjimeno@gmail.com
- Contact Person Name
- Elena Rodríguez Jimeno
- Contact Person Email
- elena.rjimeno@gmail.com
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Neumologia
- Principal Investigator Name
- Alberto Herrejon Silvestre
- Principal Investigator Email
- herrejon_alb@gva.es
- Contact Person Name
- Alberto Herrejon Silvestre
- Contact Person Email
- herrejon_alb@gva.es
Sponsor
Primary sponsor
- Full Name
- Laboratorios Liconsa S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Tiotropium Bromide Spray 2.5μg, Soft Mist Inhaler device
- Active Substance
- Tiotropium bromide
- Modality
- Small molecule
- Routes Of Administration
- Inhalation (soft mist inhaler)
- Route
- Inhalation
- Starting Dose
- 2.5μg
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