Trial Outcomes & Findings for Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion (NCT NCT02275364)
NCT ID: NCT02275364
Last Updated: 2017-08-02
Results Overview
Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.
COMPLETED
PHASE4
28 participants
Upto 2.5 hours
2017-08-02
Participant Flow
Participants were recruited at a clinical site in London.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
|
Period 1
COMPLETED
|
12
|
14
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
|
Washout Period 1
STARTED
|
12
|
14
|
|
Washout Period 1
COMPLETED
|
12
|
14
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
12
|
14
|
|
Period 2
COMPLETED
|
12
|
14
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Washout Period 2
STARTED
|
12
|
14
|
|
Washout Period 2
COMPLETED
|
12
|
14
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
12
|
14
|
|
Period 3
COMPLETED
|
12
|
14
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
|
Period 4
STARTED
|
12
|
14
|
|
Period 4
COMPLETED
|
12
|
14
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 1
Other reason
|
1
|
0
|
Baseline Characteristics
Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion
Baseline characteristics by cohort
| Measure |
Overall
n=28 Participants
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.
|
|---|---|
|
Age, Continuous
|
33.0 Years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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.
Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.
Outcome measures
| Measure |
Test Nasal Strip
n=21 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=21 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
n=21 Participants
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
Test Nasal Strip Plus Decongestant
n=21 Participants
Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
|
|---|---|---|---|---|
|
Anatomical Measures : Cross Sectional Area
|
133.22 mm^2
Standard Deviation 28.946
|
116.88 mm^2
Standard Deviation 31.468
|
156.48 mm^2
Standard Deviation 29.103
|
176.12 mm^2
Standard Deviation 29.370
|
PRIMARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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
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.
Outcome measures
| Measure |
Test Nasal Strip
n=25 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=25 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
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.
|
|---|---|---|---|---|
|
Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task
|
7.39 % Signal
Standard Deviation 9.858
|
7.92 % Signal
Standard Deviation 8.246
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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.
Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.
Outcome measures
| Measure |
Test Nasal Strip
n=21 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=21 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
n=21 Participants
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
Test Nasal Strip Plus Decongestant
n=21 Participants
Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
|
|---|---|---|---|---|
|
Anatomical Measure: Volume (Single Volume Reading)
|
13407.42 mm^3
Standard Deviation 3199.592
|
11732.85 mm^3
Standard Deviation 3254.077
|
15770.79 mm^3
Standard Deviation 3596.181
|
17680.49 mm^3
Standard Deviation 3691.798
|
PRIMARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Test Nasal Strip
n=21 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=21 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
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.
|
|---|---|---|---|---|
|
Cerebral Blood Flow (CBF)
|
85.80 ml/100g/min
Standard Deviation 23.351
|
86.25 ml/100g/min
Standard Deviation 20.079
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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.
Determination of averaged volume reading during the MRI (Average of 8 sub-regions)
Outcome measures
| Measure |
Test Nasal Strip
n=21 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=21 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
n=21 Participants
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
Test Nasal Strip Plus Decongestant
n=21 Participants
Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
|
|---|---|---|---|---|
|
Anatomical Measures: Volume (Multiple Volume Reading)
|
1675.93 mm^3
Standard Deviation 399.949
|
1466.61 mm^3
Standard Deviation 406.760
|
1971.35 mm^3
Standard Deviation 449.523
|
2210.06 mm^3
Standard Deviation 461.475
|
PRIMARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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.
Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.
Outcome measures
| Measure |
Test Nasal Strip
n=25 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=25 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
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.
|
|---|---|---|---|---|
|
Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)
|
0.13 % signal change
Standard Deviation 0.123
|
0.12 % signal change
Standard Deviation 0.161
|
—
|
—
|
SECONDARY outcome
Timeframe: Upto 2.5 hoursPopulation: 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
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.
Outcome measures
| Measure |
Test Nasal Strip
n=25 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=25 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
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.
|
|---|---|---|---|---|
|
Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)
Functional Connectivity (% signal change)
|
0.42 % signal change
Standard Deviation 0.261
|
0.33 % signal change
Standard Deviation 0.249
|
—
|
—
|
|
Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)
Event-related (% signal change)
|
27.57 % signal change
Standard Deviation 40.038
|
10.80 % signal change
Standard Deviation 43.793
|
—
|
—
|
SECONDARY outcome
Timeframe: Upto 30 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Test Nasal Strip
n=26 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
n=26 Participants
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
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.
|
|---|---|---|---|---|
|
Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application
Immediate Change from Baseline (Units on a scale)
|
-0.46 Units on a scale
Standard Deviation 1.067
|
-0.07 Units on a scale
Standard Deviation 0.900
|
—
|
—
|
|
Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application
30 minutes Change from Baseline (Units on a scale)
|
-1.00 Units on a scale
Standard Deviation 1.296
|
-0.42 Units on a scale
Standard Deviation 1.629
|
—
|
—
|
SECONDARY outcome
Timeframe: Upto 2 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Test Nasal Strip
n=26 Participants
Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
|
Placebo Nasal Strip
Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
|
Decongestant
A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
|
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.
|
|---|---|---|---|---|
|
VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration
Change from baseline post-decongestant use
|
-1.35 Units on a scale
Standard Deviation 1.522
|
—
|
—
|
—
|
|
VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration
Change from baseline (Nasal Strip + Decongestant)
|
-1.69 Units on a scale
Standard Deviation 1.436
|
—
|
—
|
—
|
Adverse Events
Marketed Nasal Strip
Placebo Nasal Strip
Decongestant
Marketed Nasal Strip Plus Decongestant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER