Clinical trial NCT01105949: An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency
Official title: An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: nasal patency
acoustic rhinometry
nasal strip
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
measure: Change from baseline in total nasal volume of the nose using acoustic rhinometry
timeFrame: baseline to within 2 hours post application
Secondary outcomes:
measure: Nasal airway breathing as measured by Posterior Rhinomanometry
timeFrame: Baseline to 2 hours
measure: Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Baseline to 2 hours
measure: Subjective perceptions of airway breathing
timeFrame: Baseline to 2 hours
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Common Cold Centre
state: Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.