Last updated: 11/07/2018 12:28:53
Functional Magnetic Resonance Imaging (fMRI) study of Nasal strips in Nasal congestion
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Magnetic Resonance Imaging Study of Nasal Strips in Subjects with Nasal Congestion
Trial description: The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis techniques derived from physiological data collected during scanning.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Anatomical Measures : Cross Sectional Area
Timeframe: Upto 2.5 hours
Functional brain activity: Blood Oxygen Level Dependent- Interoceptive Attention task
Timeframe: Upto 2.5 hours
Anatomical Measure: Volume (Single volume reading)
Timeframe: Upto 2.5 hours
Cerebral Blood Flow (CBF)
Timeframe: Upto 2.5 hours
Anatomical Measures: Volume (Multiple Volume Reading)
Timeframe: Upto 2.5 hours
Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention task (Psychophysiological interactive analysis)
Timeframe: Upto 2.5 hours
Secondary outcomes:
Breathing-related cortical activity (Blood Oxygen Level Dependent- Resting State)
Timeframe: Upto 2.5 hours
Verbal Numerical Response (VNR): Change from baseline to immediately after strip application and 30 minutes post application
Timeframe: Upto 30 minutes
VNR: Change from baseline to 20 minutes after Decongestant administration, and post application of the Marketed Nasal Strip after Decongestant administration
Timeframe: Upto 2 hours
Interventions:
Device: Test strip
Device: Placebo strip
Other: Nasal spray
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2013-30-10
Time perspective:
Not applicable
Clinical publications:
Laryngoscope. 2016 Oct;126(10):2205-11. doi: 10.1002/lary.25906. Epub 2016 Feb 10
Medical condition
Nasal Congestion
Product
oxymetazoline
Collaborators
Not applicable
Study date(s)
August 2013 to October 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale
- Participants with a nasal congestion frequency score of 1, 2, 3 or 4.
- Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose
- Use of any medications like nasal decongestant, alpha adrenergic drugs, glucocorticoids and any current treatment which in the opinion of the investigator will affect nasal congestion
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale
- Participants with a nasal congestion frequency score of 1, 2, 3 or 4.
Exclusion criteria:
- Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose
- Use of any medications like nasal decongestant, alpha adrenergic drugs, glucocorticoids and any current treatment which in the opinion of the investigator will affect nasal congestion
- Known or suspected intolerance or hypersensitivity to the study materials.
Trial location(s)
Location
Imanova Centre for Imaging Sciences
London, Not Available, United Kingdom, W12 0NN
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-30-10
Actual study completion date
2013-30-10
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website