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This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover, 2-center (conducted in EU; The Netherlands) study in male and female subjects with stable, mild HDM-allergic asthma.
This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover, 2-center (conducted in EU; The Netherlands) study in male and female subjects with stable, mild HDM-allergic asthma. The study will consist of two identical study periods of 12 treatment days each, separated by a washout period of at least 3 weeks (and no more than 7 weeks). Approximately 36 eligible subjects will be enrolled, to yield 32 evaluable subjects who will be treated with both FP-025 (400 mg BID) or matching placebo in a cross-over design from the evening of Day 1 till the morning of Day 12 (22 doses per study period in total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 mg FP-025 capsules | Active Comparator | 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 Placebo Capsules | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP-025 capsules | Drug | FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Late Asthmatic Response (LAR) | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | FeNO measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma |
Inclusion Criteria:
The following criteria must be met by all subjects considered for study participation:
Females or males, between 18 and 55 years of age at Screening, inclusive, on the day of signing the Informed Consent Form (ICF).
Apart from a clinically stable asthma and HDM-allergy, subjects should be generally healthy with no history of a clinically relevant medical condition that in the opinion of the investigator might interfere with successful study conduct and no clinically relevant abnormalities on medical history, physical exam, vital signs, laboratory parameters or ECG at Screening.
Subject has a BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 (and weighs ≥50 kg).
Subjects have been diagnosed with asthma cf GINA guidelines.
Subjects should have established allergy for HDM (serum HDM-specific IgE or positive SPT at Screening or documented within 1 year pre-screening).
No severe exacerbation of asthma within past 1 year requiring hospital admission and/or treatment with oral corticosteroids; no (never) intensive care admissions for asthma or intubation).
FEV1 should be ≥70% of predicted on Screening Day 2.
On Screening Day 2, PC20FEV1(Meth) should be <16 mg/mL if methacholine chloride is used (or adjusted by a factor of 1.2 if methacholine bromide is used).
Baseline blood eosinophils should be ≥150 cells/μL at Screening or documented within 3 months before Screening Day 1.
Subjects should have a documented airway late response to inhaled HDM on Screening Day 3.
Subjects of childbearing potential must be willing to use adequate contraception (double-barrier) or must refrain from intercourse.
Female subjects of non-childbearing potential must have had
≥ 12 months of spontaneous amenorrhea (with folliclestimulating hormone [FSH] ≥ 30 mIU/mL). Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (for 'benign' reasons), or bilateral tubal ligation.
All female subjects should have a negative pregnancy test at Screening and on Day -1.
Negative alcohol breath test on Screening Day 1 and Day -1.
Negative cotinine test on Screening Day 1 and Day -1.
Negative urine drug screen for recreational and other drugs on Screening Day 1 and Day -1.
Subjects are non-smokers. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening Day 1. Number of years smoked x number of packs per day should be <5 pack years.
Subject should be willing and able to perform the lung function tests and other study-related procedures and comply with study protocol requirements.
Subject should provide a signed and dated informed consent.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zuzana Diamant, MD, PhD | QPS Netherlands | Principal Investigator |
| Rene Lutter | Academic Medical Centre/University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Centre/University of Amsterdam, Department of Respiratory Medicine and Experiment Immunology | Amsterdam | 1105 AZ | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | FP-025 - Placebo | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
|
Fifteen Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FP-025 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yisheng Lee, MD, Chief Medical Officer | Foresee Pharmaceuticals | 4088234807 | yisheng.lee@foreseepharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2021 | Feb 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2023 | Feb 29, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2021 | Apr 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000713213 | FP-025 |
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|
| Placebo FP-025 capsules | Drug | 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. | Early asthmatic response (EAR) expressed as FEV1 AUC0-3h in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Early Asthmatic Response (EAR). | 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. | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Joint HDM-induced Airway Response. | Joint HDM-induced airway response expressed as FEV1 AUC0-8h post-allergen in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma patients. | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Airway Hyper-responsiveness | 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. | 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 Asthma |
| 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) | Small airway parameters measured by IOS R5(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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) |
| The Effect of Study Treatments on Allergen (HDM)-Induced Changes in Blood Eosinophils, Day 10 vs Day 12. | Changes in allergen-induced airway and systemic biomarkers (i.e. eosinophils (blood) (Day 10 versus Day12) (potential treatment effect). | 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 Asthma |
| To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 1 Versus Day 10), Through Measurement of PC20FEV1. | Changes in PC20FEV1(Meth) or PC20FEV1(Hist) Day 1 versus Day 10 (potential treatment effect) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. | 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 Asthma |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R20. | Small airway parameters measured by IOS R20(AUC3-8h)) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R5 - R20. | Small airway parameters measured by IOS R5-R20(AUC3-8h)) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS AX. | Small airway parameters measured by IOS Ax(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS X5. | Small airway parameters measured by IOS X5(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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) |
| Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS FRES. | Small airway parameters measured by IOS Fres(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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) |
| The Effect of Study Treatments on Allergen (HDM)-Induced Changes in Blood Eosinophils, Day 1 vs Day 10. | Changes in allergen-induced airway and systemic biomarkers (i.e. eosinophils (blood) (Day 1 versus Day 10) (potential treatment effect). | Blood eosinophils measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma |
| 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). | 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. | FeNO measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma |
| QPS Netherlands - Clinical Pharmacology Unit | Groningen | 9713 GZ | Netherlands |
| Adverse Event |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Placebo - FP-025 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| FEV1 % predicted | Mean | Standard Deviation | % predicted |
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| OG000 |
| FP-025 |
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. |
| OG001 | Placebo | 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. |
|
|
| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Late Asthmatic Response (LAR) | 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 | 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. | Posted | Mean | Standard Deviation | Maximal percentage fall | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in EAR. | Early asthmatic response (EAR) expressed as FEV1 AUC0-3h in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Early Asthmatic Response (EAR). | 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. | 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. | Posted | Mean | Standard Deviation | Maximal percentage fall | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Joint HDM-induced Airway Response. | Joint HDM-induced airway response expressed as FEV1 AUC0-8h post-allergen in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma patients. | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Airway Hyper-responsiveness | 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. | 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. | Posted | Mean | Standard Deviation | mg/mL | 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 Asthma |
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| Secondary | 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) | Small airway parameters measured by IOS R5(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | The Effect of Study Treatments on Allergen (HDM)-Induced Changes in Blood Eosinophils, Day 10 vs Day 12. | Changes in allergen-induced airway and systemic biomarkers (i.e. eosinophils (blood) (Day 10 versus Day12) (potential treatment effect). | 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. | Posted | Mean | Standard Deviation | 10^9 Eosinophils/L | 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 Asthma |
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| Secondary | To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 1 Versus Day 10), Through Measurement of PC20FEV1. | Changes in PC20FEV1(Meth) or PC20FEV1(Hist) Day 1 versus Day 10 (potential treatment effect) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma. | 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. | Posted | Mean | Standard Deviation | mg/mL | 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 Asthma |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R20. | Small airway parameters measured by IOS R20(AUC3-8h)) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS R5 - R20. | Small airway parameters measured by IOS R5-R20(AUC3-8h)) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS AX. | Small airway parameters measured by IOS Ax(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS X5. | Small airway parameters measured by IOS X5(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Secondary | Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Small Airway Parameters Following HDM-challenge, IOS FRES. | Small airway parameters measured by IOS Fres(AUC3-8h) during LAR post-allergen challenge in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma | 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. | Posted | Mean | Standard Deviation | h*% | 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) |
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| Other Pre-specified | 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). | 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. | 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 | Posted | Mean | Standard Deviation | ppb | FeNO measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma |
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| Other Pre-specified | 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). | 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. | 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 | Posted | Mean | Standard Deviation | ppb | FeNO measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma |
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| Secondary | The Effect of Study Treatments on Allergen (HDM)-Induced Changes in Blood Eosinophils, Day 1 vs Day 10. | Changes in allergen-induced airway and systemic biomarkers (i.e. eosinophils (blood) (Day 1 versus Day 10) (potential treatment effect). | 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. | Posted | Mean | Standard Deviation | 10^9 Eosinophils/L | Blood eosinophils measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma |
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| 0 |
| 23 |
| 0 |
| 23 |
| 16 |
| 23 |
| EG001 | Placebo | 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. | 0 | 26 | 0 | 26 | 12 | 26 |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Upper Abdominal Pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Dry Throat | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Epistaxis | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
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Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |