Common ColdNCT05126407
A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
An observational study of Common Cold and Sinusitis, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Sinusitis, Hypersensitivity
- How many people
- 87 participants
- Where
- 1 siteGermany
- Study dates
- 17 Dec 2021to 20 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Common Cold, Sinusitis, Hypersensitivity
- Medical subject headings
- Common Cold, Sinusitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 month and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start17 Dec 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akash Pandhare, MD. Ph.D., Principal investigator, Johnson & Johnson Consumer Inc. (J&JCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126407
- Sponsor's protocol ID
- CCSURA003229
- Other IDs
- CCSURA003229
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 7074822Chirico 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.
PubMed 25336097Eichel 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.
PubMed 23621514Koksal 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.
PubMed 27513397
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05126407
- Acronym / sponsor ID
- CCSURA003229
- Conditions
- Common Cold, Sinusitis, Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops
Time frame: Up to 1 month and 14 days
Participant feedback on the performance aspects of Olynth Nasal Saline Drops will be assessed via electronic survey.
Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray
Time frame: Up to 1 month and 14 days
Participant feedback on the performance aspects of Olynth Nasal Saline Spray will be assessed via electronic survey.
Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray
Time frame: Up to 1 month and 14 days
Participant feedback on the performance aspects of Olynth Ectomed Nasal Spray will be assessed via electronic survey.
Number of Participants with Adverse Events (AEs)
Time frame: Up to 1 month and 14 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 7074822Spector 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.
- Background: PubMed 25336097Chirico 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.
- Background: PubMed 23621514Eichel 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.
- Background: PubMed 27513397Koksal 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akash Pandhare, MD. Ph.D. principal investigator
Johnson & Johnson Consumer Inc. (J&JCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Cold and Sinusitis, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops (time frame: Up to 1 month and 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05126407, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.