Last updated: 11/04/2018 05:40:42
An evaluation of two novel nasal strip prototypes on nasal patency
GSK study ID
B3560645
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An evaluation of two novel Breathe Right Nasal Strip prototypes on nasal patency
Trial description: The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
Timeframe: baseline to within 2 hours post application
Change from baseline in total nasal volume of the nose using acoustic rhinometry
Timeframe: baseline to within 2 hours post application
Secondary outcomes:
Nasal airway breathing as measured by Posterior Rhinomanometry
Timeframe: Baseline to 2 hours
Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)
Timeframe: Baseline to 2 hours
Subjective perceptions of airway breathing
Timeframe: Baseline to 2 hours
Interventions:
Device: Marketed nasal strip
Device: NexGen AB 2R11
Device: NexGen JB Organic PET/PE
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2009-31-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy volunteer
Product
Breathe Right
Collaborators
Not applicable
Study date(s)
September 2009 to October 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
- Currently experiencing cold or flu
- History of perennial or allergic rhinitis or rhinitis medicamentosa
Inclusion and exclusion criteria
Inclusion criteria:
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
Exclusion criteria:
- 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
- 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 location(s)
Location
Common Cold Centre
Cardiff, Wales, United Kingdom, Not Available
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2009-31-10
Actual study completion date
2009-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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