Trial Outcomes & Findings for Cockroach Nasal Allergen Challenge Pilot (NCT NCT02710136)
NCT ID: NCT02710136
Last Updated: 2018-09-25
Results Overview
Result is the proportion of participants (Pss) responding at each of 9 CA doses during the NAC.To illustrate the variability of the outcome at each dose,the protocol specifies computation of 95% CIs for the proportion responding at each dose.A proportion is to record for each Ps a 0 for non-responder and 1 for responder \&compute the mean of the 0 \&1 values.Summary statistic for this method: a mean. After each dose,TNSS \&TNSS Sneezing scores were recorded.TNSS (0-12) is a self-rated score computed as the sum of 4 subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, \& itchy nose symptoms (sxs).Pss provide a score on each subscale of 0, 1, 2, or 3(none, mild, moderate, or severe sxs, respectively).Pss cont'd receiving doses until either a TNSS (≥8 in adults,≥6 in children) or sneezing score threshold \[TLV\] of 3 was met.Assumption: Pss met TLV criteria for doses not recv'd beyond dose at which TLV criteria were initially met.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
NAC Baseline through last dose of German cockroach allergen administered during the NAC
Results posted on
2018-09-25
Participant Flow
Of the 182 participants recruited, 80 participants consented to be screened for study eligibility. Among the five participating clinical research sites, all located in the United States, 35 participants enrolled to participate in the study. Enrollment was active from February 2016 to March 2017.
Participant milestones
| Measure |
Cockroach Sensitive Adults With Asthma
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Study Enrollment
STARTED
|
10
|
25
|
|
Study Enrollment
COMPLETED
|
10
|
25
|
|
Study Enrollment
NOT COMPLETED
|
0
|
0
|
|
Phase 1a[Refer to Arm/Group Description]
STARTED
|
10
|
0
|
|
Phase 1a[Refer to Arm/Group Description]
COMPLETED
|
9
|
0
|
|
Phase 1a[Refer to Arm/Group Description]
NOT COMPLETED
|
1
|
0
|
|
Phase 1b[Refer to Arm/Group Description]
STARTED
|
4
|
0
|
|
Phase 1b[Refer to Arm/Group Description]
COMPLETED
|
4
|
0
|
|
Phase 1b[Refer to Arm/Group Description]
NOT COMPLETED
|
0
|
0
|
|
Phase 2 [Refer to Arm/Group Description]
STARTED
|
0
|
25
|
|
Phase 2 [Refer to Arm/Group Description]
COMPLETED
|
0
|
25
|
|
Phase 2 [Refer to Arm/Group Description]
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cockroach Sensitive Adults With Asthma
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Phase 1a[Refer to Arm/Group Description]
Adverse Event
|
1
|
0
|
Baseline Characteristics
Cockroach Nasal Allergen Challenge Pilot
Baseline characteristics by cohort
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 7.5 • n=93 Participants
|
11.2 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
15.5 years
STANDARD_DEVIATION 8.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
German cockroach allergen Bla g 1, Bla g 2, or Bla g 5 ng/g levels in home dust above LLD (yes/no)
|
1 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
German cockroach allergen skin test wheal size (mm)
|
6.2 mm
STANDARD_DEVIATION 1.6 • n=93 Participants
|
5.6 mm
STANDARD_DEVIATION 1.5 • n=4 Participants
|
5.8 mm
STANDARD_DEVIATION 1.5 • n=27 Participants
|
|
German cockroach allergen IgE (kU/L)
|
3.61 kU/L
STANDARD_DEVIATION 4.60 • n=93 Participants
|
3.48 kU/L
STANDARD_DEVIATION 4.61 • n=4 Participants
|
3.52 kU/L
STANDARD_DEVIATION 4.50 • n=27 Participants
|
|
Total Nasal Symptom Score (TNSS)
|
0.50 Scores on a Scale
STANDARD_DEVIATION 0.71 • n=93 Participants
|
1.04 Scores on a Scale
STANDARD_DEVIATION 1.06 • n=4 Participants
|
0.89 Scores on a Scale
STANDARD_DEVIATION 0.99 • n=27 Participants
|
|
Peak Nasal Inspiratory Flow (PNIF) L/min
|
150.5 L/min
STANDARD_DEVIATION 36.1 • n=93 Participants
|
108.8 L/min
STANDARD_DEVIATION 37.8 • n=4 Participants
|
120.7 L/min
STANDARD_DEVIATION 41.4 • n=27 Participants
|
|
Peak Expiratory Flow (PEF) L/min
|
362.5 L/min
STANDARD_DEVIATION 103.3 • n=93 Participants
|
303.0 L/min
STANDARD_DEVIATION 88.9 • n=4 Participants
|
320.0 L/min
STANDARD_DEVIATION 95.6 • n=27 Participants
|
|
Visual Analog Score (VAS)
|
0.12 Centimeters
STANDARD_DEVIATION 0.26 • n=93 Participants
|
1.07 Centimeters
STANDARD_DEVIATION 1.88 • n=4 Participants
|
0.80 Centimeters
STANDARD_DEVIATION 1.64 • n=27 Participants
|
|
Log base 10 Tryptase in Nasal Secretions
|
0.49 mcg/L
STANDARD_DEVIATION 0.69 • n=93 Participants
|
0.84 mcg/L
STANDARD_DEVIATION 0.73 • n=4 Participants
|
0.71 mcg/L
STANDARD_DEVIATION 0.72 • n=27 Participants
|
|
Log base 10 Albumin in Nasal Secretions
|
5.39 mcg/L
STANDARD_DEVIATION 0.69 • n=93 Participants
|
5.80 mcg/L
STANDARD_DEVIATION 0.44 • n=4 Participants
|
5.67 mcg/L
STANDARD_DEVIATION 0.55 • n=27 Participants
|
PRIMARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
Result is the proportion of participants (Pss) responding at each of 9 CA doses during the NAC.To illustrate the variability of the outcome at each dose,the protocol specifies computation of 95% CIs for the proportion responding at each dose.A proportion is to record for each Ps a 0 for non-responder and 1 for responder \&compute the mean of the 0 \&1 values.Summary statistic for this method: a mean. After each dose,TNSS \&TNSS Sneezing scores were recorded.TNSS (0-12) is a self-rated score computed as the sum of 4 subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, \& itchy nose symptoms (sxs).Pss provide a score on each subscale of 0, 1, 2, or 3(none, mild, moderate, or severe sxs, respectively).Pss cont'd receiving doses until either a TNSS (≥8 in adults,≥6 in children) or sneezing score threshold \[TLV\] of 3 was met.Assumption: Pss met TLV criteria for doses not recv'd beyond dose at which TLV criteria were initially met.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 1 - 0 mcg/mL
|
0.00 Cumulative proportion of participants
Interval 0.0 to 0.31
|
0.12 Cumulative proportion of participants
Interval 0.03 to 0.31
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 2 - 0.00381 mcg/mL
|
0.00 Cumulative proportion of participants
Interval 0.0 to 0.31
|
0.16 Cumulative proportion of participants
Interval 0.05 to 0.36
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 3 - 0.01204 mcg/mL
|
0.10 Cumulative proportion of participants
Interval 0.0 to 0.45
|
0.16 Cumulative proportion of participants
Interval 0.05 to 0.36
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 4 - 0.0380 mcg/mL
|
0.22 Cumulative proportion of participants
Interval 0.03 to 0.6
|
0.32 Cumulative proportion of participants
Interval 0.15 to 0.54
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 5 - 0.120 mcg/mL
|
0.44 Cumulative proportion of participants
Interval 0.14 to 0.79
|
0.48 Cumulative proportion of participants
Interval 0.28 to 0.69
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 6 - 0.379 mcg/mL
|
0.56 Cumulative proportion of participants
Interval 0.21 to 0.86
|
0.64 Cumulative proportion of participants
Interval 0.43 to 0.82
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 7 - 1.20 mcg/mL
|
0.56 Cumulative proportion of participants
Interval 0.21 to 0.86
|
0.72 Cumulative proportion of participants
Interval 0.51 to 0.88
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 8 - 3.78 mcg/mL
|
0.56 Cumulative proportion of participants
Interval 0.21 to 0.86
|
0.76 Cumulative proportion of participants
Interval 0.55 to 0.91
|
|
Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)
Dose 9 - 11.9 mcg/mL
|
0.67 Cumulative proportion of participants
Interval 0.3 to 0.93
|
0.80 Cumulative proportion of participants
Interval 0.59 to 0.93
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
Nine increasing doses of German cockroach allergen (0, 0.00381, 0.01204, 0.0380, 0.120, 0.379, 1.20, 3.78, and 11.9 mcg/mL) were administered during the Nasal Allergen Challenge (NAC). After administration of each dose, the number of times the participant sneezed was recorded. Participants continued receiving doses of German cockroach allergen until threshold criteria described in the primary endpoint were met. Number of sneezes was carried forward for doses not received beyond the dose at which the threshold criteria were initially met. Number of sneezes is summarized at each dose.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 1 - 0 mcg/mL
|
0.00 Count of sneezes
Standard Deviation 0.00
|
0.32 Count of sneezes
Standard Deviation 0.99
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 2 - 0.00381 mcg/mL
|
0.00 Count of sneezes
Standard Deviation 0.00
|
0.76 Count of sneezes
Standard Deviation 1.64
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 3 - 0.01204 mcg/mL
|
0.50 Count of sneezes
Standard Deviation 0.97
|
0.64 Count of sneezes
Standard Deviation 1.41
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 4 - 0.0380 mcg/mL
|
1.40 Count of sneezes
Standard Deviation 2.55
|
1.56 Count of sneezes
Standard Deviation 2.48
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 5 - 0.120 mcg/mL
|
3.10 Count of sneezes
Standard Deviation 3.63
|
2.80 Count of sneezes
Standard Deviation 3.62
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 6 - 0.379 mcg/mL
|
3.80 Count of sneezes
Standard Deviation 4.42
|
4.04 Count of sneezes
Standard Deviation 4.61
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 7 - 1.20 mcg/mL
|
4.00 Count of sneezes
Standard Deviation 4.27
|
4.20 Count of sneezes
Standard Deviation 4.49
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 8 - 3.78 mcg/mL
|
4.10 Count of sneezes
Standard Deviation 4.23
|
4.48 Count of sneezes
Standard Deviation 4.48
|
|
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Dose 9 - 11.9 mcg/mL
|
4.40 Count of sneezes
Standard Deviation 4.25
|
4.68 Count of sneezes
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants provide a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. The highest TNSS observed after administration of any of the German cockroach allergen doses received during the Nasal Allergen Challenge (NAC) is summarized.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Highest Total Nasal Symptom Score (TNSS)
|
5.20 Scores on a Scale
Standard Deviation 3.05
|
5.16 Scores on a Scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Change is computed by subtracting the TNSS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge from the TNSS score obtained at the last tolerated dose of German cockroach allergen received during the Nasal Allergen Challenge (NAC). A positive change score indicates that nasal symptoms increased over the course of the NAC.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Change in Total Nasal Symptom Score (TNSS)
|
4.40 Scores on a Scale
Standard Deviation 3.17
|
3.96 Scores on a Scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
PNIF is defined as the speed of inspiration of air in Liters per minute when breathing into the lungs. Change is computed by subtracting the PNIF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PNIF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A negative change score indicates that speed of inspiration decreased over the course of the NAC.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Change in Peak Nasal Inspiratory Flow (PNIF) L/Min
|
-33.5 L/min
Standard Deviation 44.5
|
-18.8 L/min
Standard Deviation 34.0
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
PEF is defined as the speed of expiration of air in Liters per minute when breathing out of the lungs. Change is computed by subtracting the PEF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PEF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that speed of expiration increased over the course of the Challenge, while a negative change score indicates speed of expiration decreased over the course of the NAC.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Change in Peak Expiratory Flow (PEF) L/Min
|
25.0 L/min
Standard Deviation 57.0
|
-5.2 L/min
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC
Participants self-reported their score, reflecting the severity of their nasal symptoms-sneezing, runny nose, stuffy nose, itchy nose- on a Visual Analogue Scale (0 to 10 centimeters). The left-hand side of the scale (0) represents "No Symptoms," and the right hand side of the scale (10) represents "As Bad as I Can Imagine." Change is computed by subtracting the VAS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the VAS score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that nasal symptoms increased over the course of the NAC.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Change in Visual Analogue Score
|
1.82 Centimeters
Standard Deviation 1.66
|
1.44 Centimeters
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline tryptase measurement.
Tryptase is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the tryptase level prior to the Nasal Allergen Challenge (NAC) from the tryptase level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that tryptase levels increased over the course of the NAC.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=17 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Change in Log Base 10 Tryptase in Nasal Secretions
|
0.55 mcg/L
Standard Deviation 0.52
|
0.25 mcg/L
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: NAC Baseline through last dose of German cockroach allergen administered during the NACPopulation: Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline albumin measurement.
Albumin is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the albumin level prior to the Nasal Allergen Challenge (NAC) from the albumin level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that albumin levels increased over the course of the NAC.
Outcome measures
| Measure |
Cockroach Sensitive Adults With Asthma
n=10 Participants
In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=17 Participants
In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|
|
Change in Log Base 10 Albumin in Nasal Secretions
|
0.32 mcg/L
Standard Deviation 0.61
|
0.19 mcg/L
Standard Deviation 0.35
|
Adverse Events
Phase 1a Cockroach Sensitive Adults With Asthma
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1b Cockroach Sensitive Adults With Asthma
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cockroach Sensitive Children With Asthma
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1a Cockroach Sensitive Adults With Asthma
n=10 participants at risk
Adverse events captured during Screening and Phase 1a are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to return for a second nasal allergen challenge in Phase 1b to assess the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Phase 1b Cockroach Sensitive Adults With Asthma
n=4 participants at risk
Adverse events captured during Phase 1b are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 participants at risk
Adverse events captured during Phase 2 are included. In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|---|
|
Infections and infestations
Herpes simplex
|
10.0%
1/10 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
Other adverse events
| Measure |
Phase 1a Cockroach Sensitive Adults With Asthma
n=10 participants at risk
Adverse events captured during Screening and Phase 1a are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to return for a second nasal allergen challenge in Phase 1b to assess the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Phase 1b Cockroach Sensitive Adults With Asthma
n=4 participants at risk
Adverse events captured during Phase 1b are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen.
|
Cockroach Sensitive Children With Asthma
n=25 participants at risk
Adverse events captured during Phase 2 are included. In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3.
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
General disorders
Xerosis
|
10.0%
1/10 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Immune system disorders
Anaphylactic reaction
|
10.0%
1/10 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
25.0%
1/4 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Investigations
Peak expiratory flow rate decreased
|
10.0%
1/10 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 3 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
25.0%
1/4 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
8.0%
2/25 • Number of events 2 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
10.0%
1/10 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
4.0%
1/25 • Number of events 1 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/10 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/4 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
0.00%
0/25 • Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place