Clinical trial NCT05126407: A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Cold
Sinusitis
Hypersensitivity
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops
timeFrame: Up to 1 month and 14 days
measure: Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray
timeFrame: Up to 1 month and 14 days
measure: Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray
timeFrame: Up to 1 month and 14 days
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 1 month and 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Schlesinger Group
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Akash Pandhare, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.