Clinical trial • Phase III • Respiratory

Salbutamol for Mild Asthma

Phase III trial of Salbutamol for Mild Asthma. 84 participants.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Mild Asthma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-06-2024
First CTIS Authorization Date
18-09-2024

Trial design

Phase III trial across 7 sites in Germany, Romania, Bulgaria and others.

Target Sample Size
84

Recruitment

Planned Sample Size
84
Recruitment Window Months
5

Geography

Total Number Of Sites
7
Total Number Of Participants
66

Germany

Earliest CTIS Part Ii Submission Date
19-08-2024
Latest Decision Or Authorization Date
18-09-2024
Processing Time Days
30
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
Department Name
Clinical Airway Research
Contact Person Name
Philipp Badorrek

Romania

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
95
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Centrul Medical Monza S.R.L.
Department Name
Wards 1, 2, 3, 4, 5, 6,7
Contact Person Name
Ionela Camelia Nita
Contact Person Email
camelia.nita@arensia-em.com
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Ophtalmology building, Wards 33, 34, 35
Contact Person Name
Andrei Lesan

Bulgaria

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
27-09-2024
Processing Time Days
92
Number Of Sites
3
Number Of Participants
26

Sites

Site Name
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department Name
Department of Internal Diseases
Contact Person Name
Radostina Cherneva
Site Name
Medical Center Comac Medical Ltd.
Department Name
Not Applicable
Contact Person Name
Iva Popova
Contact Person Email
iva.popova@comac-medical.com
Site Name
Medical Center Comac Medical Ltd.
Department Name
Not Applicable
Contact Person Name
Iva Popova
Contact Person Email
iva.popova@comac-medical.com

Poland

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Biokinetica S.A.
Department Name
ND
Contact Person Name
Monika Tomaszewska -Kiecana
Contact Person Email
monika.kiecana@biokinetica.com

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
Salbutamol (metered dose inhaler)
Active Substance
Salbutamol
Modality
Small molecule
Routes Of Administration
Inhalation (metered dose inhaler)
Route
Inhalation

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