Otrivine: QoL impact in a real-world setting
Research type
Research Study
Full title
A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment with Otrivine (Xylometazoline hydrochloride).
IRAS ID
1006069
Contact name
Yoshita Anandarajah
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited
ISRCTN Number
ISRCTN74996920
Research summary
Research Summary
This study is to see if an over-the-counter nasal spray can improve quality of life for people suffering with a blocked nose with the common cold. The drug being tested is called Otrivine (xylometazoline hydrochloride) which helps to open up and clear the nasal passages by reducing the excessive secretions in the nose and returning swollen blood vessels to their normal size.
A blocked nose with a common cold is one of the most bothersome symptoms of the common cold and has been shown to have a significant impact on the quality of life, work productivity, absence from work, and sleep quality. This study will help to see if Otrivine can help to relieve the symptoms of a blocked nose and whether this can improve the quality of life of those suffering with this illness.
Participants will be informed about the study and give their informed consent to take part. They will then complete a screening questionnaire which will include details about their cold symptoms, medical history and medication use. If confirmed to be eligible, the study drug will be shipped to their home. Participants whose symptoms started within 24 hours of starting screening and who continue to meet the defined symptom severity threshold at the time of product receipt will be eligible. Participants will take part in the study for approximately 8 days. During that time, they will take Otrivine up to 3 times per day for a maximum of 7 days. They will also complete a questionnaire which will take approximately 5-10 minutes per day.
This study will take place at one virtual site located in England and will recruit approximately 125 adults.Summary of Results
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05556148%253Fterm%253D218317%2526rank%253D1%2526tab%253Dresults%2FNBTI%2FD5_1AQ%2FAQ%2F7b6f93d1-931b-4213-a194-674d4a0d5173%2F2%2F9auIpFKLHa&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C03c4fa94b177458977d908dc7f284c37%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638525058267128442%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=Ra8rzzcYxux1xfJKgLFi9Clt0G1hcpA5YIpSeB0hrv8%3D&reserved=0
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0177
Date of REC Opinion
27 Oct 2022
REC opinion
Further Information Favourable Opinion