A phase III study of the safety and efficacy of povidone-iodine nasal spray (Nasodine”) in the treatment of subjects with the common cold in the natural setting.

Firebrick Pharma Pty Ltd0 个研究点目标入组 256 人开始时间: 2019年5月22日最近更新: 2020年1月6日

适应症

试验速览

暂无简介。

•1.Confirm age (18-65) and access to smartphone
•2.Subject must report at least two of the following cold symptoms – sneezing, runny nose, nasal congestion, or sore throat – and have a total Jackson score of at least 3 points
•3.Cold symptoms for less than 60 hours prior at enrolment; time and date of symptom onset will be noted
•4. The PI or MO establishes a diagnosis of the common cold based on examination of presenting symptoms and medical history

•1.Fever greater than 38C or abnormal vital signs
•2.Known iodine sensitivity
•3.Known thyroid disease
•4.Known immunodeficiency
•5.Chronic respiratory diseases, including asthma, chronic cough, COPD, chronic allergic rhinitis or otherwise using chronic inhaled corticosteroids
•6.Pregnant or nursing (lactating) or planning to become pregnant during the study
•7.Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or lower respiratory tract infection
•8.Have any medical condition(s) deemed by the PI to interfere with assessments; this includes any nasal abnormalities as determined by nasal examination at enrolment.
•9.Taking any prescription medication deemed by the MO to affect assessment of the investigational product
•10.Intending to use during the study, OTC cold medications that could influence study results (antihistamines, decongestant nasal sprays, combination cough/cold medications); paracetamol will be available as a rescue medication for any disabling symptoms.
•11.Intending to use a povidone-iodine gargle during the study
•12.Unwilling to sign the informed consent form (PICF)

发起方

Firebrick Pharma Pty Ltd