Healthy SubjectsPhase 1NCT01495494
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
A Phase 1 study testing Marketed Nasal Strip and Prototype Nasal Dilator in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study evaluated the safety \& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Marketed Nasal Strip and Prototype Nasal Dilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2009
- Phase
- Phase 1
- 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
Who may be able to join
- Healthy subjects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated the safety \& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.
- Conditions
- Healthy Subjects
- Being tested
- Marketed Nasal Strip, Prototype Nasal Dilator
- Keywords
- Nasal Strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Nasal StripDevice
Breathe Right Nasal Strips - Clear small/medium strip
Prototype Nasal DilatorDevice
Prototype Nasal Dilator AB2R11
| Study group | Role | What they receive |
|---|---|---|
| Marketed nasal strip | Active comparator | Marketed nasal strip Receives: Device: Marketed Nasal Strip |
| Prototype nasal dilator | Experimental | Prototype nasal dilator Receives: Device: Prototype Nasal Dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal response score of the application site of the nasal strip
Measured: Baseline through 7 days
Secondary outcomes (1)
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495494
- Sponsor's protocol ID
- B3560692
- Status last verified
- Jun 2014
- First submitted
- 16 Dec 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ward J, Ciesla R, Becker W, Shanga GM. Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Allergy Rhinol (Providence). 2018 Oct 5;9:2152656718796740. doi: 10.1177/2152656718796740. eCollection 2018 Jan-Dec.
PubMed 30305980
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
- ClinicalTrials.gov ID
- NCT01495494
- Acronym / sponsor ID
- B3560692
- Conditions
- Healthy Subjects
- Keywords
- Nasal Strip
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Dec 2011 (estimated)
- 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.
This study evaluated the safety \& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed nasal strip | Active comparator | Device: Marketed Nasal StripMarketed nasal strip |
| Prototype nasal dilator | Experimental | Device: Prototype Nasal DilatorPrototype nasal dilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marketed Nasal StripBreathe Right Nasal Strips - Clear small/medium strip | Device | Marketed nasal strip |
| Prototype Nasal DilatorPrototype Nasal Dilator AB2R11 | Device | Prototype nasal dilator |
Primary outcome
Dermal response score of the application site of the nasal strip
Time frame: Baseline through 7 days
1 secondary outcome
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
Time frame: 7 days
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 24 Nov 2014.
- Derived from this study: PubMed 30305980Ward J, Ciesla R, Becker W, Shanga GM. Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Allergy Rhinol (Providence). 2018 Oct 5;9:2152656718796740. doi: 10.1177/2152656718796740. eCollection 2018 Jan-Dec.
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Healthy Participants
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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marketed Nasal Strip and Prototype Nasal Dilator in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
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 1 inclusion and 0 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 24 Nov 2014. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dermal response score of the application site of the nasal strip (time frame: Baseline through 7 days). 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 NCT01495494, which also lists 1 linked publication.
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 24 Nov 2014.