Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo nasal strip | Placebo Comparator | Placebo nasal strip to be applied for up to two hours in either of the first two scans only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test strip | Device | Class I device for the application to the nose to facilitate better air flow through the nose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical Measures : Cross Sectional Area | Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans. | 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. | 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. | 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. | Upto 2.5 hours |
| Anatomical Measures: Volume (Multiple Volume Reading) | Determination of averaged volume reading during the MRI (Average of 8 sub-regions) | Upto 2.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imanova Centre for Imaging Sciences | London | W12 0NN | United Kingdom |
A total of 35 participants were screened of which 28 were randomized in the study. Five of these did not meet study criteria, 1 had a protocol violation and 1 additional participant had other reason to leave the study, prior to be randomized.
Participants were recruited at a clinical site in London.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | In the sequence 1 of the crossover part of the study, participants were randomized to receive placebo strip first (period 1) followed by marketed strip (period 2). The placebo strip was applied for up to two hours for the first scanning sessions, and then removed and the marketed strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3 |
| FG001 | Sequence 2 | In the sequence 1 of the crossover part of the study, participants were randomized to receive marketed strip first (period 1) followed by marketed strip (period 2). The marketed strip was applied for up to two hours for the first scanning sessions, and then removed and the placebo strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Washout Period 1 |
| ||||||||||||||||||||||
| Period 2 |
| ||||||||||||||||||||||
| Washout Period 2 |
| ||||||||||||||||||||||
| Period 3 |
| ||||||||||||||||||||||
| Period 4 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants were randomized to receive either Marketed Nasal Strip or Placebo Nasal Strip (to be applied for up to two hours in either of the first two scans only). During the third scanning session, Marketed Nasal Strip was applied for approximately 20 minutes after administration of a Marketed Decongestant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anatomical Measures : Cross Sectional Area | Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans. | Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards. | Posted | Mean | Standard Deviation | mm^2 | Upto 2.5 hours |
|
AEs were collected from the start of the investigational product and until 5 days following last administration of the investigational product.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Marketed Nasal Strip | Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
Not provided
Not provided
| ID | Term |
|---|---|
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo strip | Device | Placebo strip |
|
| Nasal spray | Other | Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions. |
|
| 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. | Upto 2.5 hours |
| 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. | 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. | Upto 2 hours |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only. |
| OG002 | Decongestant | A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session. |
| OG003 | Test Nasal Strip Plus Decongestant | Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant. |
|
|
|
| Primary | 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. | Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to analyze effect on nasal strips on the brain activity without the use of nasal decongestant | Posted | Mean | Standard Deviation | % Signal | Upto 2.5 hours |
|
|
|
|
| Primary | Anatomical Measure: Volume (Single Volume Reading) | Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI. | Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards. | Posted | Mean | Standard Deviation | mm^3 | Upto 2.5 hours |
|
|
|
|
| Primary | 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. | Decongestant and Test Nasal Strip Plus Decongestant groups were not evaluated in this outcome measure as it was pre-specified to to analyze effect of nasal strips on the cerebral blood without the use of nasal decongestant. | Posted | Mean | Standard Deviation | ml/100g/min | Upto 2.5 hours |
|
|
|
|
| Primary | Anatomical Measures: Volume (Multiple Volume Reading) | Determination of averaged volume reading during the MRI (Average of 8 sub-regions) | Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards. | Posted | Mean | Standard Deviation | mm^3 | Upto 2.5 hours |
|
|
|
|
| Primary | 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. | Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to evaluate the effect on nasal strips on the measure of brain activity without the use of nasal decongestant. | Posted | Mean | Standard Deviation | % signal change | Upto 2.5 hours |
|
|
|
|
| Secondary | 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. | Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was prespecified to evaluate the effect on nasal strips on the breathing related brain activity without the use of nasal decongestant | Posted | Mean | Standard Deviation | % signal change | Upto 2.5 hours |
|
|
|
| Secondary | 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. | Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards. | Posted | Mean | Standard Deviation | Units on a scale | Upto 30 minutes |
|
|
|
| Secondary | 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. | Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards. | Posted | Mean | Standard Deviation | Units on a scale | Upto 2 hours |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Placebo Nasal Strip | Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only. | 0 | 28 | 0 | 28 |
| EG002 | Decongestant | A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session. | 0 | 28 | 0 | 28 |
| EG003 | Marketed Nasal Strip Plus Decongestant | Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant. | 0 | 28 | 0 | 28 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Pharmaceutical Preparations |