Trial Outcomes & Findings for A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber (NCT NCT00848965)
NCT ID: NCT00848965
Last Updated: 2012-09-24
Results Overview
The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Day 8 of each study period (Periods 1-4); up to Day 158
Results posted on
2012-09-24
Participant Flow
Participants (par.) were randomized to receive treatment in one of five sequences in four study periods: ABCD, EABC, DEAB, CDEA, BCDE (A, Placebo; B, fluticasone propionate \[FP\] 25 micrograms \[µg\]: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). One par. randomized to ABCD withdrew due to an adverse event; one par. randomized to EABC withdrew consent.
Participant milestones
| Measure |
Placebo/FP 25, 50, 100, 200 µg
Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
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|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Placebo/FP 25, 50, 100, 200 µg
Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
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|---|---|
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Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber
Baseline characteristics by cohort
| Measure |
Placebo/FP 25, 50, 100, 200 µg
n=59 Participants
Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
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|---|---|
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Age Continuous
|
27.2 Years
STANDARD_DEVIATION 5.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian Heritage (EAH)/South EAH
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population: all participants randomized to receive at least one dose of study treatment. Only those participants contributing data at the indicated time points were analyzed.
The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=44 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=46 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=46 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
|
Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC)
|
7.17 scores on a scale
Standard Deviation 2.912
|
5.54 scores on a scale
Standard Deviation 2.437
|
5.66 scores on a scale
Standard Deviation 2.280
|
5.29 scores on a scale
Standard Deviation 2.218
|
4.77 scores on a scale
Standard Deviation 2.433
|
SECONDARY outcome
Timeframe: Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.
Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=44 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=46 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=46 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
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Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)
|
335.20 Milliliters per second (mL/s)
Standard Deviation 145.373
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368.66 Milliliters per second (mL/s)
Standard Deviation 144.230
|
375.94 Milliliters per second (mL/s)
Standard Deviation 142.105
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362.59 Milliliters per second (mL/s)
Standard Deviation 142.216
|
411.65 Milliliters per second (mL/s)
Standard Deviation 160.148
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SECONDARY outcome
Timeframe: Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.
Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=44 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=46 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=46 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
|
Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)
|
2.43 grams (g)
Standard Deviation 2.203
|
1.63 grams (g)
Standard Deviation 1.893
|
1.43 grams (g)
Standard Deviation 1.458
|
1.26 grams (g)
Standard Deviation 1.550
|
1.02 grams (g)
Standard Deviation 1.271
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SECONDARY outcome
Timeframe: Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.
The eye symptom score (total score of 0 \[none\] to 9 \[severe\]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=44 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=46 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=46 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
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Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)
|
2.35 scores on a scale
Standard Deviation 2.240
|
1.52 scores on a scale
Standard Deviation 1.678
|
1.44 scores on a scale
Standard Deviation 1.711
|
1.93 scores on a scale
Standard Deviation 1.726
|
1.41 scores on a scale
Standard Deviation 1.491
|
SECONDARY outcome
Timeframe: Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.
GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=44 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=46 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=46 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
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Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge)
|
11.14 scores on a scale
Standard Deviation 5.407
|
8.17 scores on a scale
Standard Deviation 4.302
|
8.24 scores on a scale
Standard Deviation 4.231
|
8.69 scores on a scale
Standard Deviation 4.346
|
7.13 scores on a scale
Standard Deviation 3.487
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SECONDARY outcome
Timeframe: Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population. The data presented for each period are an average of the data collected on Day 1 and Day 8 of each period. Only those participants contributing data at the indicated time points were analyzed.
AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction \[PCR\] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=12 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=12 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=12 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=12 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
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Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2
Period 1, n=12, 12, 12, 11, 11
|
12396.08096 Copies of RNA detected per 50ng of total
Interval 5928.406 to 25919.75529
|
1377.248941 Copies of RNA detected per 50ng of total
Interval 678.7116 to 2794.728503
|
1231.251053 Copies of RNA detected per 50ng of total
Interval 605.7205 to 2502.769902
|
3340.460181 Copies of RNA detected per 50ng of total
Interval 1599.611 to 6975.866146
|
3377.403394 Copies of RNA detected per 50ng of total
Interval 1625.327 to 7018.188693
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2
Period 2, n=11, 11, 11, 12, 11
|
4206.320679 Copies of RNA detected per 50ng of total
Interval 1991.881 to 8882.624596
|
2192.232108 Copies of RNA detected per 50ng of total
Interval 1015.906 to 4730.634081
|
1765.627412 Copies of RNA detected per 50ng of total
Interval 849.2589 to 3670.781431
|
2342.488506 Copies of RNA detected per 50ng of total
Interval 1127.738 to 4865.715164
|
2821.11204 Copies of RNA detected per 50ng of total
Interval 1355.137 to 5872.967075
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|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2
Period 3, n=11, 11, 11, 12, 12
|
4135.167835 Copies of RNA detected per 50ng of total
Interval 1987.132 to 8605.171059
|
3612.444351 Copies of RNA detected per 50ng of total
Interval 1730.839 to 7539.553498
|
2184.76185 Copies of RNA detected per 50ng of total
Interval 1051.383 to 4539.910315
|
1229.316666 Copies of RNA detected per 50ng of total
Interval 609.3241 to 2480.157112
|
2505.03196 Copies of RNA detected per 50ng of total
Interval 1234.885 to 5081.594294
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2
Period 4, n=12, 11, 11, 11, 12
|
10111.38124 Copies of RNA detected per 50ng of total
Interval 5019.348 to 20369.18487
|
3523.276415 Copies of RNA detected per 50ng of total
Interval 1674.529 to 7413.114228
|
2615.352938 Copies of RNA detected per 50ng of total
Interval 1249.52 to 5474.157686
|
1917.918706 Copies of RNA detected per 50ng of total
Interval 889.5355 to 4135.205377
|
1071.598621 Copies of RNA detected per 50ng of total
Interval 515.8547 to 2226.060108
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158Population: All Subjects Population. The data presented are an average of the data collected on Day 1 and Day 8 of each treatment period. Only those participants contributing data at the indicated time points were analyzed.
AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction \[PCR\] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP\_1\_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=45 Participants
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=45 Participants
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 Participants
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=46 Participants
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
PTGS2
|
42479.35246 RNA copies detected per 50 ng total RNA
Interval 34135.93482 to 52862.04685
|
31120.01509 RNA copies detected per 50 ng total RNA
Interval 24904.20116 to 38887.22762
|
35049.7556 RNA copies detected per 50 ng total RNA
Interval 28101.49486 to 43716.01489
|
38443.85612 RNA copies detected per 50 ng total RNA
Interval 30827.02769 to 47942.67187
|
33657.71928 RNA copies detected per 50 ng total RNA
Interval 27031.4341 to 41908.32284
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
18S
|
6439292568 RNA copies detected per 50 ng total RNA
Interval 5953473924.0 to 6964755253.0
|
6109603485 RNA copies detected per 50 ng total RNA
Interval 5653823536.0 to 6602125890.0
|
5822423622 RNA copies detected per 50 ng total RNA
Interval 5388052053.0 to 6291813164.0
|
6218835383 RNA copies detected per 50 ng total RNA
Interval 5759650434.0 to 6714628599.0
|
6222906532 RNA copies detected per 50 ng total RNA
Interval 5758553637.0 to 6724703483.0
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
B-actin
|
1978137.142 RNA copies detected per 50 ng total RNA
Interval 1761487.822 to 2221432.646
|
1481307.983 RNA copies detected per 50 ng total RNA
Interval 1316851.063 to 1666303.352
|
1629006.342 RNA copies detected per 50 ng total RNA
Interval 1448708.283 to 1831743.28
|
1630387.679 RNA copies detected per 50 ng total RNA
Interval 1451329.134 to 1831537.671
|
1543748.32 RNA copies detected per 50 ng total RNA
Interval 1374839.809 to 1733408.402
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
DUSP_1_T1
|
107004.8077 RNA copies detected per 50 ng total RNA
Interval 87973.18828 to 130153.6195
|
104633.517 RNA copies detected per 50 ng total RNA
Interval 85852.10596 to 127523.6379
|
107031.4158 RNA copies detected per 50 ng total RNA
Interval 88881.02888 to 128888.2916
|
118158.2593 RNA copies detected per 50 ng total RNA
Interval 97226.90284 to 143595.7933
|
113323.9632 RNA copies detected per 50 ng total RNA
Interval 91653.05005 to 140118.8573
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
FKBP5
|
28739.3975 RNA copies detected per 50 ng total RNA
Interval 24256.97193 to 34050.12675
|
155791.0745 RNA copies detected per 50 ng total RNA
Interval 131185.2632 to 185012.0837
|
174963.5715 RNA copies detected per 50 ng total RNA
Interval 147311.3952 to 207806.4043
|
177935.1307 RNA copies detected per 50 ng total RNA
Interval 150181.7514 to 210817.2961
|
151362.3934 RNA copies detected per 50 ng total RNA
Interval 127521.6515 to 179660.2684
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
GAPDH
|
5776051.293 RNA copies detected per 50 ng total RNA
Interval 5326118.123 to 6263993.356
|
6143058.472 RNA copies detected per 50 ng total RNA
Interval 5659602.91 to 6667811.859
|
6451580.253 RNA copies detected per 50 ng total RNA
Interval 5943884.286 to 7002640.993
|
6008446.351 RNA copies detected per 50 ng total RNA
Interval 5540570.46 to 6515832.227
|
5972472.493 RNA copies detected per 50 ng total RNA
Interval 5507396.953 to 6476821.624
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
GILZ
|
13601.9459 RNA copies detected per 50 ng total RNA
Interval 11833.92763 to 15634.1105
|
26629.75763 RNA copies detected per 50 ng total RNA
Interval 23090.34785 to 30711.70672
|
29304.22353 RNA copies detected per 50 ng total RNA
Interval 25490.27435 to 33688.8299
|
28832.53255 RNA copies detected per 50 ng total RNA
Interval 25122.37093 to 33090.62412
|
27304.24721 RNA copies detected per 50 ng total RNA
Interval 23763.4653 to 31372.60943
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
PLAU
|
26364.53138 RNA copies detected per 50 ng total RNA
Interval 22020.16973 to 31565.99261
|
18550.2079 RNA copies detected per 50 ng total RNA
Interval 15417.62826 to 22319.27033
|
18810.56868 RNA copies detected per 50 ng total RNA
Interval 15681.73421 to 22563.67116
|
20918.214 RNA copies detected per 50 ng total RNA
Interval 17454.94721 to 25068.63365
|
21692.66346 RNA copies detected per 50 ng total RNA
Interval 18117.03777 to 25973.98394
|
|
Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2
RGS2
|
55084.11432 RNA copies detected per 50 ng total RNA
Interval 45323.01163 to 66947.44108
|
45255.7763 RNA copies detected per 50 ng total RNA
Interval 37098.26279 to 55207.04028
|
54186.44212 RNA copies detected per 50 ng total RNA
Interval 44490.27052 to 65995.78907
|
50507.30739 RNA copies detected per 50 ng total RNA
Interval 41546.43595 to 61400.88895
|
50373.91657 RNA copies detected per 50 ng total RNA
Interval 41440.13318 to 61233.67074
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
25 µg FP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 µg FP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 µg FP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
200 µg FP
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
25 µg FP
n=46 participants at risk
Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
50 µg FP
n=46 participants at risk
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
100 µg FP
n=46 participants at risk
Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
200 µg FP
n=47 participants at risk
Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Infections and infestations
Nasopharygitis
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
4.3%
2/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.1%
1/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Nervous system disorders
Headache
|
6.5%
3/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
6.5%
3/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
2.2%
1/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/46
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
0.00%
0/47
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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