Nasal CongestionPhase 4NCT02275364
Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion
A Phase 4 study testing Test strip and Nasal spray in people with Nasal Congestion, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Test strip and Nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2013to 30 Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Imanova Centre for Imaging Sciences
London, W12 0NN
About this study
Official title: A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion
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.
- Conditions
- Nasal Congestion
- Being tested
- Test strip, Placebo strip, Nasal spray
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test stripDevice
Class I device for the application to the nose to facilitate better air flow through the nose
Placebo stripDevice
Placebo strip
Nasal sprayOther
Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.
| Study group | Role | What they receive |
|---|---|---|
| Test nasal strip | Experimental | Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes. Receives: Device: Test strip; Other: Nasal spray |
| Placebo nasal strip | Placebo comparator | Placebo nasal strip to be applied for up to two hours in either of the first two scans only. Receives: Device: Placebo strip; Other: Nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Measures : Cross Sectional Area
Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.
Measured: Upto 2.5 hours
Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task
Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.
Measured: Upto 2.5 hours
Anatomical Measure: Volume (Single Volume Reading)
Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.
Measured: Upto 2.5 hours
Cerebral Blood Flow (CBF)
CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject's whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject's T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.
Measured: Upto 2.5 hours
Anatomical Measures: Volume (Multiple Volume Reading)
Determination of averaged volume reading during the MRI (Average of 8 sub-regions)
Measured: Upto 2.5 hours
Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)
Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.
Measured: Upto 2.5 hours
Secondary outcomes (3)
Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)
Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change.
Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties.
Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type.
Measured: Upto 2.5 hours
Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application
Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.
Measured: Upto 30 minutes
VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration
Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.
Measured: Upto 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study start5 Aug 2013
- Primary completion30 Oct 2013
- Study completion30 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal CongestionStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 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
- NCT02275364
- Sponsor's protocol ID
- 202178
- Status last verified
- Jun 2017
- First submitted
- 22 May 2014
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion
- ClinicalTrials.gov ID
- NCT02275364
- Acronym / sponsor ID
- 202178
- Conditions
- Nasal Congestion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2013 (actual)
- Primary completion
- 30 Oct 2013 (actual)
- Study completion
- 30 Oct 2013 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test nasal strip | Experimental | Device: Test strip, Other: Nasal sprayMarketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes. |
| Placebo nasal strip | Placebo comparator | Device: Placebo strip, Other: Nasal sprayPlacebo nasal strip to be applied for up to two hours in either of the first two scans only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Test stripClass I device for the application to the nose to facilitate better air flow through the nose | Device | Test nasal strip |
| Placebo stripPlacebo strip | Device | Placebo nasal strip |
| Nasal sprayNasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions. | Other | Placebo nasal strip, Test nasal strip |
Primary outcome
Anatomical Measures : Cross Sectional Area
Time frame: Upto 2.5 hours
Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.
Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task
Time frame: Upto 2.5 hours
Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.
Anatomical Measure: Volume (Single Volume Reading)
Time frame: Upto 2.5 hours
Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.
Cerebral Blood Flow (CBF)
Time frame: Upto 2.5 hours
CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject's whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject's T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.
Anatomical Measures: Volume (Multiple Volume Reading)
Time frame: Upto 2.5 hours
Determination of averaged volume reading during the MRI (Average of 8 sub-regions)
Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)
Time frame: Upto 2.5 hours
Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.
3 secondary outcomes
Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)
Time frame: Upto 2.5 hours
Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application
Time frame: Upto 30 minutes
VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration
Time frame: Upto 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nasal Congestion
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Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
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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 4 study testing Test strip and Nasal spray in people with Nasal Congestion, 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 2 inclusion and 3 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 2 Aug 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anatomical Measures : Cross Sectional Area (time frame: Upto 2.5 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2017.