A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
January 31, 2023 updated by: Johnson & Johnson Consumer Inc. (J&JCI)
A Non-Interventional Clinical Study to Assess the Risk and Performance Aspects of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, D-10789
- Schlesinger Group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants who has personally used or administered the Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray to a child will be included.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops
Time Frame: Up to 1 month and 14 days
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Participant feedback on the performance aspects of Olynth Nasal Saline Drops will be assessed via electronic survey.
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Up to 1 month and 14 days
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Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray
Time Frame: Up to 1 month and 14 days
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Participant feedback on the performance aspects of Olynth Nasal Saline Spray will be assessed via electronic survey.
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Up to 1 month and 14 days
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Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray
Time Frame: Up to 1 month and 14 days
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Participant feedback on the performance aspects of Olynth Ectomed Nasal Spray will be assessed via electronic survey.
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Up to 1 month and 14 days
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Number of Participants with Adverse Events (AEs)
Time Frame: Up to 1 month and 14 days
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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.
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Up to 1 month and 14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Akash Pandhare, MD. Ph.D., Johnson & Johnson Consumer Inc. (J&JCI)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 17, 2021
Primary Completion (ACTUAL)
January 20, 2022
Study Completion (ACTUAL)
January 20, 2022
Study Registration Dates
First Submitted
November 3, 2021
First Submitted That Met QC Criteria
November 18, 2021
First Posted (ACTUAL)
November 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCSURA003229 (OTHER: Johnson & Johnson Consumer Inc. (J&JCI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.