The effect of FP-025, a MMP-12 inhibitor, on allergen induced airway responses, airway inflammation and aspects of airway remodeling in subjects with mild eosinophilic House Dust Mite (HDM)-allergic asthma
- Conditions
- AsthmaCOPD10038716
- Registration Number
- NL-OMON55388
- Lead Sponsor
- Foresee Pharmaceuticals Co., Ltd
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1. Females or males, between 18 and 55 years of age at Screening, inclusive, on
the day of signing the Informed Consent Form (ICF).
2. 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.
3. Subject has a BMI >= 18.0 kg/m2 and <= 32.0 kg/m2 (and weighs >=50 kg).
4. Subjects have been diagnosed with asthma cf GINA guidelines.
5. Subjects should have established allergy for HDM (serum HDM-specific IgE or
positive SPT at Screening or documented within 1 year pre-screening).
6. 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).
7. FEV1 should be >=70% of predicted on Screening Day 2.
8. 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). If histamine is used, PC20FEV1(Hist) should be <16 mg/mL.
9. Baseline blood eosinophils should be >=150 cells/µL at Screening or
documented within 3 months before Screening Day 1.
10. Subjects should have a documented airway late response to inhaled HDM on
Screening Day 3.
11. Subjects of childbearing potential must be willing to use adequate
contraception (double-barrier) or must refrain from intercourse.
12. Female subjects of non-childbearing potential must have had >= 12 months of
spontaneous amenorrhea (with follicle-stimulating 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.
13. All female subjects should have a negative pregnancy test at Screening and
on Day -1.
14. Negative alcohol breath test on Screening Day 1 and Day -1.
15. Negative cotinine test on Screening Day 1 and Day -1.
16. Negative urine drug screen for recreational and other drugs on Screening
Day 1 and Day -1.
17. 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.
18. Subject should be willing and able to perform the lung function tests and
other study-related procedures and comply with study protocol requirements.
19. Subject should provide a signed and dated informed consent.
1. Subject has any active and/or chronic (physical or mental) condition
requiring maintenance (pharmaco)therapy or which otherwise precludes subject
from safe or adequate study participation (ineligibility will be assessed by
the PI).
2. Subject has a history of cancer (exception: localized basalioma or cervix
carcinoma in situ).
3. Subject had any major (nasal) surgery in the 6 months before Screening Day 1.
4. Subject is pregnant or lactating.
5. Subject is using immunotherapy that according to the PI may interfere with
the study (e.g. in case of immunotherapy with HDM or when subject is in the
updosing phase of any immunotherapy).
6. Subject regularly used alcohol (intake of >21 units/wk for males and >14
units/wk for females) and/or recreational drugs within the last 6 months prior
to screening.
7. Subject had any respiratory (viral) infections (e.g. common cold) within 3
weeks of Screening Day 1 or on Day -1.
8. Subject is using maintenance asthma therapy or long-acting bronchodilators
or any other anti-asthma or anti-allergic medications (as detailed in the
protocol) other than infrequent use of SABA prn only.
9. Subject is using prohibited medications as detailed in the protocol.
10. Multi-sensitized symptomatic subjects with seasonal (pollen) allergies
should be included outside of the relevant allergen season and/or should not be
in frequent contact with the relevant allergen during the study.
11. Subject has any known allergic response for the medications used or known
severe allergic reactions or anaphylaxis (to food/medications/insect venoms).
12. Subject participated in medical studies in the past 3 months
(non-biologicals) or in the past 6 months (biologicals).
13. Subject is anticipated not to comply with study medication or other aspects
of the study (at the discretion of the investigator).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Spirometry:<br /><br>• Area under the time-FEV1 response curve from 3 to 8 hours post-allergen (FEV1<br /><br>AUC3-8h)</p><br>
- Secondary Outcome Measures
Name Time Method