Sinusitis Clinical Trial
Official title:
A Non-Interventional Clinical Study to Assess the Risk and Performance Aspects of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
| Verified date | January 2023 |
| Source | Johnson & Johnson Consumer and Personal Products Worldwide |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to proactively collect customer feedback on the performance aspects and risk factors of Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray.
| Status | Completed |
| Enrollment | 87 |
| Est. completion date | January 20, 2022 |
| Est. primary completion date | January 20, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Aged 18 years or older who has personally used or administered the nasal drops/spray to a child - Has personally used or administered to a child, the Nasal Drops/Spray at least once within the past 6 months - Able to read, write, speak, and understand German - Has internet access to complete an on-line survey - Intends to complete the survey - Individual has signed the informed consent document (ICD) Exclusion Criteria: - Is an employee/contractor or immediate family member of the principal investigator (PI), Schlesinger group, product perceptions limited (PPL) Insights or sponsor of this study |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Schlesinger Group | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Johnson & Johnson Consumer Inc. (J&JCI) |
Germany,
Chirico G, Quartarone G, Mallefet P. Nasal congestion in infants and children: a literature review on efficacy and safety of non-pharmacological treatments. Minerva Pediatr. 2014 Dec;66(6):549-57. — View Citation
Eichel A, Wittig J, Shah-Hosseini K, Mosges R. A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragees) in patients with acute rhinosinusitis. Curr Med Res Opin. 2013 Jul;29(7):739-46. doi: 10.1185/03007995.2013.800474. Epub 2013 May 14. — View Citation
Koksal T, Cizmeci MN, Bozkaya D, Kanburoglu MK, Sahin S, Tas T, Yuksel CN, Tatli MM. Comparison between the use of saline and seawater for nasal obstruction in children under 2 years of age with acute upper respiratory infection. Turk J Med Sci. 2016 Jun 23;46(4):1004-13. doi: 10.3906/sag-1507-18. — View Citation
Spector SL, Toshener D, Gay I, Rosenman E. Beneficial effects of propylene and polyethylene glycol and saline in the treatment of perennial rhinitis. Clin Allergy. 1982 Mar;12(2):187-96. doi: 10.1111/j.1365-2222.1982.tb01638.x. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops | Participant feedback on the performance aspects of Olynth Nasal Saline Drops will be assessed via electronic survey. | Up to 1 month and 14 days | |
| Primary | Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray | Participant feedback on the performance aspects of Olynth Nasal Saline Spray will be assessed via electronic survey. | Up to 1 month and 14 days | |
| Primary | Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray | Participant feedback on the performance aspects of Olynth Ectomed Nasal Spray will be assessed via electronic survey. | Up to 1 month and 14 days | |
| Primary | Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, whether or not related to the investigational device. | Up to 1 month and 14 days |
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