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.

Phase 3

Completed

• Conditions: Common Cold; Infection - Other infectious diseases

• Registration Number: ACTRN12619000764134
• Lead Sponsor: Firebrick Pharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-22
• Study Completion: 2019-11-27
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
asal symptom score over days 1-5: Total score of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) questionnaire items: Runny nose, plugged nose, sneezing, and head congestion, [WURSS-21 completed once daily on Days 1-5. ]