Evaluation of Free Air Portable Air Powered Respirator (NCT02487147) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Free Air Portable Air Powered Respirator
United States58 participantsStarted 2016-11-14
Plain-language summary
This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR) system versus a N95 mask in preventing nasal detection of influenza following an exposure. The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95 respirator at interrupting the exposure of the study participants to aerosolized influenza virus particles.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Age 18-49 years of age
* Employee or student at Wake Forest University School of Medicine and Wake Forest University
Exclusion Criteria:
* Respiratory tract disorders and other chronic diseases, and medical conditions and treatments which are contraindications to mask usage
* Severe claustrophobia or inability to tolerate masks
* Contraindications to FluMist:
* Children younger than 18 years; proposed age range is 18-49
* Adults 50 years and older; proposed age range is 18-49
* People who have received the live attenuated influenza vaccine within 3 weeks of the exposure sessions
* People with a history of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine
* People who are allergic to eggs
* Pregnant women
* People with weakened immune systems (immunosuppression)
* People who have taken influenza antiviral drugs within the previous 48 hours
* People who care for severely immunocompromised persons who require a protective environment (or otherwise avoid contact with those persons for 7 days after getting the nasal spray vaccine)
* People of any age with asthma might be at increased risk for wheezing after getting the nasal spray vaccine
* The safety of the nasal spray vaccine has not been established in people with underlying medical conditions that place them at high risk of serious flu complications. This includes children and adults who have lung disease, heart disease (except isolated hypertension…
What they're measuring
1
Nasal Swabs
Timeframe: Immediately following Live Attenuated Influenza Vaccine exposure
2
Nasopharyngeal swabs
Timeframe: Immediately following Live Attenuated Influenza Vaccine exposure