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| ID | Type | Description | Link |
|---|---|---|---|
| CCSURA003229 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray | Participants who have personally used or administered the Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray to a child at least once within the past 6 months will provide feedback via electronic survey on the prior use of the Drop/Spray. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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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Inclusion Criteria:
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
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Participants who has personally used or administered the Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray to a child will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Akash Pandhare, MD. Ph.D. | Johnson & Johnson Consumer Inc. (J&JCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schlesinger Group | Berlin | D-10789 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7074822 | Background | 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. | |
| 25336097 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| D012852 | Sinusitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| 23621514 | Background | 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. |
| 27513397 | Background | 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. |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007154 | Immune System Diseases |