Trial Outcomes & Findings for The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. (NCT NCT03858686)
NCT ID: NCT03858686
Last Updated: 2024-05-30
Results Overview
Late asthmatic response (LAR) is defined as FEV1 AUC3-8h; differences between FP025 and placebo in subjects with clinically stable, mild allergic asthma and blood eosinophilia.
COMPLETED
PHASE2
27 participants
FEV1 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate LAR(AUC3-8h)
2024-05-30
Participant Flow
Participant milestones
| Measure |
FP-025 - Placebo
Based on a double-blind randomized schedule, subjects will receive FP-025 capsules BID in Period 1 and matching placebo capsules BID in Period 2.
Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
|
Placebo - FP-025
Based on a double-blind randomized schedule, subjects will receive matching placebo capsules BID in Period 1 and FP-025 capsules BID in Period 2.
Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
|
|---|---|---|
|
Period 1
STARTED
|
13
|
14
|
|
Period 1
COMPLETED
|
12
|
11
|
|
Period 1
NOT COMPLETED
|
1
|
3
|
|
Washout
STARTED
|
12
|
11
|
|
Washout
COMPLETED
|
12
|
11
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
12
|
11
|
|
Period 2
COMPLETED
|
12
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
FP-025 - Placebo
Based on a double-blind randomized schedule, subjects will receive FP-025 capsules BID in Period 1 and matching placebo capsules BID in Period 2.
Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
|
Placebo - FP-025
Based on a double-blind randomized schedule, subjects will receive matching placebo capsules BID in Period 1 and FP-025 capsules BID in Period 2.
Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
|
|---|---|---|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 1
Lack of compliance
|
0
|
1
|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Baseline characteristics by cohort
| Measure |
FP-025 - Placebo
n=13 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo - FP-025
n=14 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 6.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
FEV1 % predicted
|
88.95 % predicted
STANDARD_DEVIATION 8.26 • n=5 Participants
|
92.04 % predicted
STANDARD_DEVIATION 13.3 • n=7 Participants
|
90.44 % predicted
STANDARD_DEVIATION 10.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: FEV1 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate LAR(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Late asthmatic response (LAR) is defined as FEV1 AUC3-8h; differences between FP025 and placebo in subjects with clinically stable, mild allergic asthma and blood eosinophilia.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Effect of FP-025 Versus Placebo on the Allergen (HDM)-Induced Late Asthmatic Response (LAR) in Subjects With Clinically Stable, Mild Allergic Asthma and Blood Eosinophilia.
|
-80.33 h*%
Standard Deviation 47.33
|
-113.43 h*%
Standard Deviation 48.6
|
SECONDARY outcome
Timeframe: FEV1 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate LAR(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Late asthmatic response (LAR) expressed as max% fall in FEV1 from post-diluent 3-8 h(LAR) baseline post allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Late Asthmatic Response (LAR)
|
-27.716 Maximal percentage fall
Standard Deviation 14.3153
|
-36.605 Maximal percentage fall
Standard Deviation 15.0187
|
SECONDARY outcome
Timeframe: FEV1 measured hourly from 0 to 3 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate EAR(AUC0-3h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Early asthmatic response (EAR) expressed as FEV1 AUC0-3h in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in EAR.
|
-35.748 h*%
Standard Deviation 26.2807
|
-28.683 h*%
Standard Deviation 25.4041
|
SECONDARY outcome
Timeframe: FEV1 measured hourly from 0 to 3 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate maximal% fall in FEV1(0-3h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Early asthmatic response (EAR) expressed as max% fall in FEV1 from post-diluent 0-3 h(EAR) baseline post allergen in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Early Asthmatic Response (EAR).
|
-26.070 Maximal percentage fall
Standard Deviation 14.2299
|
-20.294 Maximal percentage fall
Standard Deviation 14.5720
|
SECONDARY outcome
Timeframe: FEV1 measured hourly from 0 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate FEV1(AUC0-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Joint HDM-induced airway response expressed as FEV1 AUC0-8h post-allergen in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma patients.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Joint HDM-induced Airway Response.
|
-117.543 h*%
Standard Deviation 67.4201
|
-141.166 h*%
Standard Deviation 54.9937
|
SECONDARY outcome
Timeframe: PC20FEV1(Meth) or PC20FEV1(Hist) measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic AsthmaPopulation: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Changes in allergen-induced AHR: i.e: PC20FEV1(Meth) or PC20FEV1(Hist) pre-post allergen (Day 10 versus Day12) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Airway Hyper-responsiveness
|
0.460 mg/mL
Standard Deviation 3.4385
|
0.282 mg/mL
Standard Deviation 3.1754
|
SECONDARY outcome
Timeframe: IOS R5 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate IOS R5(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Small airway parameters measured by IOS R5(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R5 (AUC3-8 Hours)
|
186.438 h*%
Standard Deviation 113.2697
|
295.400 h*%
Standard Deviation 178.9532
|
SECONDARY outcome
Timeframe: Blood eosinophils measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic AsthmaPopulation: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Changes in allergen-induced airway and systemic biomarkers (i.e. eosinophils (blood) (Day 10 versus Day12) (potential treatment effect).
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
The Effect of Study Treatments on Allergen (HDM)-Induced Changes in Blood Eosinophils, Day 10 vs Day 12.
|
0.1061 10^9 Eosinophils/L
Standard Deviation 0.12225
|
0.1846 10^9 Eosinophils/L
Standard Deviation 0.12272
|
SECONDARY outcome
Timeframe: PC20FEV1(Meth) or PC20FEV1(Hist) measured pre-allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic AsthmaPopulation: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Changes in PC20FEV1(Meth) or PC20FEV1(Hist) Day 1 versus Day 10 (potential treatment effect) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 1 Versus Day 10), Through Measurement of PC20FEV1.
|
0.855 mg/mL
Standard Deviation 2.3187
|
1.030 mg/mL
Standard Deviation 2.0795
|
SECONDARY outcome
Timeframe: IOS R20 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate IOS R20(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Small airway parameters measured by IOS R20(AUC3-8h)) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R20.
|
62.356 h*%
Standard Deviation 51.4601
|
98.653 h*%
Standard Deviation 88.7628
|
SECONDARY outcome
Timeframe: IOS R5-R20 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate IOS R5-R20(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 17 FP-025 treated and 6 placebo treated patients.
Small airway parameters measured by IOS R5-R20(AUC3-8h)) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=17 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=6 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R5 - R20.
|
1316.841 h*%
Standard Deviation 2135.0733
|
1120.347 h*%
Standard Deviation 339.5966
|
SECONDARY outcome
Timeframe: IOS Ax measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate IOS R5-R20(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Small airway parameters measured by IOS Ax(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS AX.
|
1641.804 h*%
Standard Deviation 1338.5357
|
4446.304 h*%
Standard Deviation 6444.0241
|
SECONDARY outcome
Timeframe: IOS X5 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate IOS X5(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Small airway parameters measured by IOS X5(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS X5.
|
403.640 h*%
Standard Deviation 237.8958
|
697.189 h*%
Standard Deviation 807.5676
|
SECONDARY outcome
Timeframe: IOS Fres measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate IOS Fres(AUC3-8h)Population: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Small airway parameters measured by IOS Fres(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS FRES.
|
243.149 h*%
Standard Deviation 204.2451
|
407.199 h*%
Standard Deviation 314.7058
|
SECONDARY outcome
Timeframe: Blood eosinophils measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic AsthmaPopulation: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients.
Changes in allergen-induced airway and systemic biomarkers (i.e. eosinophils (blood) (Day 1 versus Day 10) (potential treatment effect).
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
The Effect of Study Treatments on Allergen (HDM)-Induced Changes in Blood Eosinophils, Day 1 vs Day 10.
|
0.0461 10^9 Eosinophils/L
Standard Deviation 0.09546
|
0.0211 10^9 Eosinophils/L
Standard Deviation 0.09952
|
OTHER_PRE_SPECIFIED outcome
Timeframe: FeNO measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic AsthmaPopulation: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients
FeNO is measured from exhaled air by Niox Vero® device (Circassia, Oxford, United Kingdom) according to guidelines in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 1 Versus Day 10) , Through Measurement of Fractionated Nitric Oxide (FeNO).
|
-8.12 ppb
Standard Deviation 19.258
|
-1.96 ppb
Standard Deviation 7.712
|
OTHER_PRE_SPECIFIED outcome
Timeframe: FeNO measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic AsthmaPopulation: Of the total 22 subjects who completed both periods 3 were not included in the final analysis: 1 in the FP-025-placebo sequence due to poor PFT variability throughout trial periods, 2 in the placebo-FP-025 sequence due to high deviation in the PC20FEV1(Meth) test results between period 1 and period 2. In addition, carry-over effect was detected in the period 2(placebo) data for FP-025-placebo sequence. Thus the final subjects analyzed include 19 FP-025 treated and 8 placebo treated patients
FeNO is measured from exhaled air by Niox Vero® device (Circassia, Oxford, United Kingdom) according to guidelines in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Outcome measures
| Measure |
FP-025
n=19 Participants
Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=8 Participants
Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 10 Versus Day 12), Through Measurement of Fractionated Nitric Oxide (FeNO).
|
44.94 ppb
Standard Deviation 29.952
|
67.13 ppb
Standard Deviation 41.906
|
Adverse Events
FP-025
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FP-025
n=23 participants at risk
Based on a double-blind randomized schedule, subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
Placebo
n=26 participants at risk
Based on a double-blind randomized schedule, subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.
FP-025 capsules: FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Placebo FP-025 capsules: Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
|
|---|---|---|
|
Nervous system disorders
Headache
|
21.7%
5/23 • Number of events 6 • Fifteen Weeks
|
30.8%
8/26 • Number of events 13 • Fifteen Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
21.7%
5/23 • Number of events 5 • Fifteen Weeks
|
7.7%
2/26 • Number of events 2 • Fifteen Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.0%
3/23 • Number of events 4 • Fifteen Weeks
|
7.7%
2/26 • Number of events 2 • Fifteen Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.7%
2/23 • Number of events 2 • Fifteen Weeks
|
7.7%
2/26 • Number of events 2 • Fifteen Weeks
|
|
General disorders
Fatigue
|
13.0%
3/23 • Number of events 4 • Fifteen Weeks
|
0.00%
0/26 • Fifteen Weeks
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23 • Number of events 3 • Fifteen Weeks
|
0.00%
0/26 • Fifteen Weeks
|
|
Gastrointestinal disorders
Upper Abdominal Pain
|
8.7%
2/23 • Number of events 3 • Fifteen Weeks
|
0.00%
0/26 • Fifteen Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23 • Fifteen Weeks
|
7.7%
2/26 • Number of events 2 • Fifteen Weeks
|
|
General disorders
Dry Throat
|
8.7%
2/23 • Number of events 2 • Fifteen Weeks
|
0.00%
0/26 • Fifteen Weeks
|
|
General disorders
Epistaxis
|
8.7%
2/23 • Number of events 2 • Fifteen Weeks
|
0.00%
0/26 • Fifteen Weeks
|
|
Nervous system disorders
Somnolence
|
8.7%
2/23 • Number of events 2 • Fifteen Weeks
|
0.00%
0/26 • Fifteen Weeks
|
Additional Information
Yisheng Lee, MD, Chief Medical Officer
Foresee Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place