30
Participants
Start Date
May 30, 2023
Primary Completion Date
August 1, 2023
Study Completion Date
September 30, 2023
Inhalation of Sulfurous Thermal Water
Active Inhalation protocol based on 12 consecutive sessions, 20 minutes each, once a day from Visit 1 through a conventional thermal water aerosolization Faset™system (Faset Spa, Trezzano sul Naviglio, Milan, Italy) delivering particles of TW with a diameter between 0.6 µm \<MMAD \< 5 µm. Treatment consisted of 10 minutes of warm steam and 10 minutes of aerosol inhalation with nasal prongs.
Inhalation of Sterile Distilled non-pyrogenic Water
Placebo Inhalation protocol based on 12 consecutive sessions, 20 minutes each, once a day from Visit 1 through a modified thermal water aerosolization Faset™system, previously disconnected from the hydraulic circuit that supplied TW and connected to non-pyrogenic sterile water reservoirs (Highly depurated water- Pharmaceutical grade FU-for external and internal use, Makeitlab, Canosa di Puglia, BT, Italy). Treatment consisted of 10 minutes of warm steam and 10 minutes of aerosol inhalation with nasal prongs delivering particles of SDW with a diameter between 0.6 µm \<MMAD \< 5 µm.
Acque Albule, Terme di Roma, Tivoli
Collaborators (1)
Università degli studi di Roma Foro Italico
OTHER
Queen Mary University of London
OTHER
Bios Prevention Srl
UNKNOWN
University of Roma La Sapienza
OTHER