The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (… (NCT03858686) | Clinical Trial Compass
CompletedPhase 2
The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.
Netherlands27 participantsStarted 2018-07-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
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)
. 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).
. Subject has a history of cancer (exception: localized basalioma or cervix carcinoma in situ).
. Subject had any major (nasal) surgery in the 6 months before Screening Day 1.
. Subject is pregnant or lactating.
. 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).
. 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.
. Subject had any respiratory (viral) infections (e.g. common cold) within 3 weeks of Screening Day 1 or on Day -1.
. 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.