A study to see if treatment with Otrivine (xylometazoline hydrochloride) can improve the quality of life in patients suffering with nasal congestion due to a common cold

Phase 4

Completed

Conditions: asal congestion associated with a common cold
Ear, Nose and Throat

Registration Number: ISRCTN74996920

Lead Sponsor: The Virtual Clinical Trials Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 136

Inclusion Criteria

1. Aged 18 years old and over at the signing of the informed consent
2. Reporting nasal congestion and at least one other common cold symptom among runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired
3. Reporting a minimum score of 5 (moderate) for plugged nose associated with common cold symptoms and at least one other symptom of the common cold (at least mild score of 3) as per the WURSS-21 questionnaire at screening and within 24 hours of study product receipt
4. Initiation of cold symptoms within 24 hours of initiation of screening

Exclusion Criteria

1. Allergic to xylometazoline hydrochloride or any of the other ingredients in the spray
2. Individuals who have had recent neurosurgery or self-report narrow-angle glaucoma, chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis), an enlarged prostate gland, a rare tumour of the adrenal gland that produces high amounts of adrenaline and noradrenaline (pheochromocytoma)
3. Taking monoamine oxidase inhibitors (MAOIs) or have stopped taking them in the last 14 days
4. Individuals who are pregnant, lactating, or plan to be pregnant or lactating during
the course of the study
5. Is currently using or has used a nasal decongestant (i.e. adrenergic, steroids) within the last 7 days (or for more than 7 days) prior to initiating study treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scores over time on Days 0, 1, 2, 3, 4, 5, 6, 7 in:<br>1. Wisconsin Upper Respiratory Symptom Survey – 21 (WURSS-21) total score<br>2. WURSS-21 total symptom domains<br>3. WURSS-21 total QoL domains <br>4. Each of the WURSS-21 symptom domains (10 in total)

Secondary Outcome Measures

Name	Time	Method
Post Otrivine use score on Days 1, 2, 3, 4, 5, 6, 7, for each of the following additional health-related QoL factors:<br>1. Snoring <br>2. Alertness the morning after<br>3. Feeling self-conscious about how you sound<br>4. Smell<br>5. Taste<br>6. Feeling self-conscious around people<br>7. Energy <br>8. Motivation<br><br>Safety outcome measures: to record adverse events (AEs) during the study period, including: <br>Number and percent of patients reporting AEs or serious AEs (SAEs) while on treatment that are <br>1. Related to product<br>2. Not related to product