Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
75
Countries
1
Sites
11
Chronic obstructive pulmonary disease
Key facts
- Sponsor
- Laboratorios Liconsa S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2025-09-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic obstructive pulmonary disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Liconsa S.A.
- Sponsor organisation
- Laboratorios Liconsa S.A.
- Address
- Avenida De Miralcampo 7, Poligono Industrial Miralcampo Poligono Industrial Miralcampo
- City
- Azuqueca De Henares
- Postcode
- 19200
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Liconsa S.A.
- Contact name
- Clara Paz Alvarez
Public contact point
- Organisation
- Laboratorios Liconsa S.A.
- Contact name
- Clara Paz Alvarez
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 75 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Centro de Salud Ensanche de Vallecas
Neumologia, C. de las Cinco Villas, 1, Madrid
Hospital Universitario Marques De Valdecilla
Neumologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Virgen De La Macarena
Neumologia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Bellvitge University Hospital
Neumologia, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Universitario Infanta Leonor
Neumologia, Avenida Gran Via Del Este 80, 28031, Madrid
Clinica Sagrada Familia
Neumologia, Calle Torras i Pujalt 1, 08022, Barcelona
Hospital Universitario Torrecardenas
Neumologia, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Universitario De Salamanca
Neumologia, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario La Paz
Neumologia, Paseo De La Castellana 261, 28046, Madrid
Consorci Mar Parc De Salut De Barcelona
Neumologia, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Dr Peset Aleixandre
Neumologia, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-27 | Spain | Acceptable with conditions 2025-09-12
|
2025-09-16 |