Upper respiratory tract infection (common cold) Respiratory
Conditions
Interventions
The study groups will comprise patients with symptoms of common cold, satisfying the inclusion and exclusion criteria and agreeing to take part in this randomized, double blind, controlled, parallel g
Sponsors
Church & Dwight (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptoms of common cold 2. Aged from 18 to 60 years
Exclusion criteria
Exclusion criteria: 1. Patients with symptoms started > 48 hours before enrolment. 2. Patients presenting an oral temperature greater than 38.9°C. 3. Patients with positive results on a streptococcal antigen screening test. 4. Patients with signs of lower respiratory tract disease. 5. Patients with history of allergic (seasonal or perennial) rhinitis or reporting sneezing or itching of the nose or eyes at the time of enrolment. 6. Patients with history of asthma or reporting cough, wheezing or shortness of breath at the time of enrolment. 7. Patients with current or reporting history of recurrent bronchitis, otitis or pharyngitis. 8. Patients with recent or current sinus infection (diagnosed by a physician in the past 30 days) or reporting history of recurrent sinusitis (more than two per years). 9. Patient with immune system disorder (autoimmune and immune deficiency disease such as SLE or AIDS). 10. Patients with a clinical significant cardiovascular, endocrine, neurological, respiratory, or any other current disease considered by the Investigator as an exclusion criterion, e.g. chronic respiratory or lung disease or chronic obstructive pulmonary disease (COPD). 11. Patients with severe nasal septum deviation or other current condition that can cause nasal obstruction, such as nasal polyps or nasal / sinus surgery in the past, able to influence symptoms scores. 12. Pregnant women. 13. Patients using saline nose drops or nasal sprays or pumps other than the study products, antibiotics, antivirals, nasal or systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), intranasal medicines, decongestants, antihistamines, combination cold formulae, Echinacea, supplements containing = 10 mg zinc or = 100 mg vitamin C, i.e. using OTC or prescribed medication (other than for contraception) able to influence symptoms scores at the time of enrolment. 14. Patients with known hypersensitivity or allergy to any component of the study medication or of the rescue medication (acetaminophen). 15. Patients smoking during the past 12 months. 16. Patients with a history of alcohol or drug abuse. 17. Patients participating to any investigational drug trial within 4 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Illness severity measured using Wisconsin Upper Respiratory Symptom Survey (WURSS-21) questionnaire each day. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Illness duration measured using Wisconsin Upper Respiratory Symptom Survey (WURSS-21) questionnaire each day until last time answering “Yes” to the question “Do you feel you still have a cold?” 2. Use of rescue medication measured using patient-reported diary each day 3. Patient satisfaction measured using 10-point Likert scale at the final visit of the patient to the center at the end of the study 4. Patient acceptability measured using 10-point Likert scale at the final visit of the patient to the center at the end of the study 5. Patient willingness to use the product in the future measured using 4-point scale at the final visit of the patient to the center at the end of the study 6. Safety measured using means of the assessment of all the adverse or serious adverse events reported during the study recorded to patient diary | — |
Countries
Italy
Outcome results
None listed