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
- Contact Person Email
- philipp.badorrek@item.fraunhofer.de
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
- Contact Person Email
- andrei.lesan.ext@arensia-em.com
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
- Contact Person Email
- radostina.cherneva.ext@arensia-em.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
- 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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