A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

NCT ID: NCT05126407

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-17

Study Completion Date

2022-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Common Cold Sinusitis Hypersensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akash Pandhare, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johnson & Johnson Consumer Inc. (J&JCI)

Locations

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Schlesinger Group

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 7074822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25336097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23621514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27513397 (View on PubMed)

Other Identifiers

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CCSURA003229

Identifier Type: OTHER

Identifier Source: secondary_id

CCSURA003229

Identifier Type: -

Identifier Source: org_study_id

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