Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Su… (NCT02340130) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
Spain57 participantsStarted 2014-09
Plain-language summary
This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.
Who can participate
Age range
18 Years – 70 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
. Subject has provided appropriately signed and dated written informed consent.
. Men and women aged 18 years and 70 years of age at Visit 1.
. Has an FEV1 value 80% of predicted normal value at Visit 1.
. Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.
. Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
. If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile.
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
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions
Timeframe: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.
. If a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study.
Exclusion criteria
. Any contraindication for treatment with allergen specific immunotherapy.
. Subjects with a previous history of anaphylaxis.
. Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
. Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010).
. Acute or chronic infectious conjunctivitis.
. Has acute or chronic inflammatory or infectious airways disease.
. Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
. History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.