Healthy VolunteerPhase 1NCT01105949
An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency
A Phase 1 study testing Marketed nasal strip, NexGen AB 2R11 and NexGen JB Organic PET/PE in people with Healthy Volunteer, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Marketed nasal strip, NexGen AB 2R11 and NexGen JB Organic PET/PE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Oct 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
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
Who cannot join
- Currently experiencing cold or flu
- History of perennial or allergic rhinitis or rhinitis medicamentosa
- Evidence of nasal polyps as documented by anterior rhinoscopy
- Evidence of significant nasal tract structural malformations including a severe deviated septum (where subjects are indicated for surgery) or a concha bullosa as documented by anterior rhinoscopy
- Visible open sores, sunburn, irritation, eczema or chronic skin condition on the face to nose
- Bacterial sinusitis infection during 2 weeks prior to entry in the baseline phase of the study
Show all 14Show fewer
- Any other condition that in the opinion of the investigator would have an affect on nasal breathing
- Use of any product containing menthol within two hours prior to any subjective measures involved in the study
- Had an allergic contact dermatitis on the face within 30 days prior to entry
- History of chronic or active skin or other immunologic (rheumatoid, psoriasis) disease
- History of skin cancer
- Use of antibiotics or alpha adrenergic drugs (all forms) within 1 week prior to entry in the baseine phase of the study
- Use of glucocorticosteroids (all forms) within 1 month prior to entry in the baseline phase of the study
- Any current treatment which in the opinion of the investigator will affect nasal congestion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency
The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.
- Conditions
- Healthy Volunteer
- Being tested
- Marketed nasal strip, NexGen AB 2R11, NexGen JB Organic PET/PE
- Keywords
- nasal patency, acoustic rhinometry, nasal strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed nasal stripDevice
Marketed nasal strip
NexGen AB 2R11Device
Nasal strip prototype
NexGen JB Organic PET/PEDevice
Nasal strip
| Study group | Role | What they receive |
|---|---|---|
| Marketed nasal strip | Other | Marketed nasal strip Receives: Device: Marketed nasal strip |
| NexGen JB Organic PET/PE | Experimental | NexGen JB Organic PET/PE, prototype nasal dilator strip Receives: Device: NexGen JB Organic PET/PE |
| NexGen AB 2R11 | Experimental | NexGen AB 2R11 Receives: Device: NexGen AB 2R11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
Measured: baseline to within 2 hours post application
Change from baseline in total nasal volume of the nose using acoustic rhinometry
Measured: baseline to within 2 hours post application
Secondary outcomes (3)
Nasal airway breathing as measured by Posterior Rhinomanometry
Measured: Baseline to 2 hours
Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)
Measured: Baseline to 2 hours
Subjective perceptions of airway breathing
Measured: Baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2009
- Study completionOct 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 VolunteerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT01105949
- Sponsor's protocol ID
- B3560645
- Status last verified
- Jan 2012
- First submitted
- 15 Apr 2010
- Last updated
- 30 Jan 2012
- 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 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency
- ClinicalTrials.gov ID
- NCT01105949
- Acronym / sponsor ID
- B3560645
- Conditions
- Healthy Volunteer
- Keywords
- nasal patency, acoustic rhinometry, nasal strip
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Apr 2010 (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.
The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marketed nasal strip | Other | Device: Marketed nasal stripMarketed nasal strip |
| NexGen JB Organic PET/PE | Experimental | Device: NexGen JB Organic PET/PENexGen JB Organic PET/PE, prototype nasal dilator strip |
| NexGen AB 2R11 | Experimental | Device: NexGen AB 2R11NexGen AB 2R11 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
Key exclusion criteria (14 listed)
- Currently experiencing cold or flu
- History of perennial or allergic rhinitis or rhinitis medicamentosa
- Evidence of nasal polyps as documented by anterior rhinoscopy
- Evidence of significant nasal tract structural malformations including a severe deviated septum (where subjects are indicated for surgery) or a concha bullosa as documented by anterior rhinoscopy
- Visible open sores, sunburn, irritation, eczema or chronic skin condition on the face to nose
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 stripMarketed nasal strip | Device | Marketed nasal strip |
| NexGen AB 2R11Nasal strip prototype | Device | NexGen AB 2R11 |
| NexGen JB Organic PET/PENasal strip | Device | NexGen JB Organic PET/PE |
Primary outcome
Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
Time frame: baseline to within 2 hours post application
Change from baseline in total nasal volume of the nose using acoustic rhinometry
Time frame: baseline to within 2 hours post application
3 secondary outcomes
Nasal airway breathing as measured by Posterior Rhinomanometry
Time frame: Baseline to 2 hours
Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline to 2 hours
Subjective perceptions of airway breathing
Time frame: Baseline to 2 hours
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 30 Jan 2012.
- 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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Screening Protocol
Pain
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, NexGen AB 2R11 and NexGen JB Organic PET/PE in people with Healthy Volunteer, run by GlaxoSmithKline at 1 site in United Kingdom.
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 14 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 30 Jan 2012. 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 Kingdom. 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?
Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry (time frame: baseline to within 2 hours post application). The study lists 2 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 NCT01105949, 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 30 Jan 2012.