Safety evaluation of low-level chlorine in water aerosol when inhaled by healthy volunteers

Phase 1

Completed

• Conditions: Safety evaluation of nebulised HS4-20 physiologic aqueous chlorine aerosol; Respiratory

• Registration Number: ISRCTN13034712
• Lead Sponsor: Hypo-Stream Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-20
• Study Start: 2021-12-15
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Healthy volunteers, no exclusions on basis of age or gender

Exclusion Criteria

Does not meet the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events measured using observation for the absence of abnormality and of coordination by a clinically trained investigator over a 30-minute period following administration. Follow-up was 7 days post-administration self-reporting. The final follow-up was over a 12-month period of self-reporting and investigator interview.

Secondary Outcome Measures

Name	Time	Method
1. Blood pressure measured with an automatic upper arm cuff sphygmomanometer (Omron X3) at baseline (pre-administration), 30 seconds, 2, 5, 10, 20, 30 minutes post-administration in first and second cohorts, the third cohort was measured at 30 seconds, 5, 20, 30 minutes<br>2. Oxygen saturation measured by pulse oximeter (Braun Healthcare Pulse Oximeter 1) throughout the periods of exposure and for 30 minutes after cessation of administration