BridgeMD
Tests treatment safety and results for Rhinitis
Official title Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
ClinicalTrials.gov ID: NCT07348302
What this study is testing
What is Allergen Immunotherapy Extract?
Allergen Immunotherapy Extract is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for rhinitis.
Also referred to as ORALTEK®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- Participants who have signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 65 years, both included, at the time of signature of ICF.
- Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis...
- Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus...
- Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause...
You likely can't join if
- Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the...
- Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical...
- Asthmatic participants with forced expiratory volume in the first second (FEV1) \<80% (following at least a 6-hour washout of short-acting beta2...
- Participants with uncontrolled asthma, according to GINA 2022,(2) asthma with poor symptom control (frequent symptoms or reliever use, activity...
- Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler...
- Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.
See the full eligibility criteria
Who can join
- Participants who have signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 65 years, both included, at the time of signature of ICF.
- Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year of duration...
- Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as...
- Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 month after the end of treatment with the investigational medicinal product (IMP). Such methods...
- Participants capable of complying with dosage regimen.
- Participants owning a smartphone to register symptoms and medication consumption.
- Participants not sensitized to any other clinically relevant allergen or sensitized with the following characteristics (sensitization to other allergens will be assessed through skin prick test in Europe and LATAM and...
- Participants sensitized to dander (with a positive skin prick test for dander or IgE ≥ 0.35 kU/L), provided that they have occasional exposure and symptoms.
- Participants sensitized to endemic pollen (with a positive skin prick test or IgE ≥0.35 kU/L) will be scheduled to be included so that the pollen season does not coincide with the Baseline Evaluation Period nor with one...
- Participants not sensitized to moulds, cockroach, Blomia tropicalis or other geographically relevant mites (negative skin prick test or IgE \< 0.7 kU/L).
- Participants with a RCSMS ≥ 3 out of 6 recorded for at least 10 days during the baseline evaluation period, corresponding to moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
- Participants with specific IgE against a complete extract of D. pteronyssinus and / or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5kU/L.
What rules you out
- Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy [OIT], milk, or egg) before the...
- Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)
- Asthmatic participants with forced expiratory volume in the first second (FEV1) \<80% (following at least a 6-hour washout of short-acting beta2 agonists [SABA] and 12-hour washout of long-acting beta2 agonists [LABA])...
- Participants with uncontrolled asthma, according to GINA 2022,(2) asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and/or frequent...
- Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
- Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.
- Participants on treatment with immunosuppressive or biological drugs.
- Participants who had not had a long enough washout/withdrawal period at the first screening visit (S1) according to criteria in the study protocol (See Table 6 in section 9.5.3) before undergoing allergen diagnostic...
- Unstable participants who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to first screening visit (S1).
- Participants who have suffered chronic urticaria, severe anaphylaxis, or with hereditary angioedema history within 2 years prior to the first screening visit (S1).
- Participants having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator's criteria.
- Participants with other severe diseases not related to allergic rhinitis or asthma that could interfere with the study treatment or the follow-up.
- Participants with severe and unresponsive to treatment autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases or immunodeficiencies.
- Participants that could not comply with the study protocol, according to the investigator's criteria, or have a serious mental illness.
- Participants with known allergy to any of the components of the study treatment other than study allergens.
- Participants who had a complication(s) of any nasal disease (including nasal polyp, nasal septal deviation, and hypertrophic rhinitis, drug-induced rhinitis and/or non-allergic rhinitis) affecting an appropriate...
- Participants who had a nasal surgery within 6 months prior to the first screening visit (S1) or have programmed or anticipated nasal surgery during the trial period.
- Participants with a lesion in the oral cavity that could confound the safety profile of the study treatment, according to the investigator's criteria.
- Participants who required treatment with antihistamines and/or corticosteroids for other purposes than alleviating symptoms of allergic rhinitis (except temporal use for diseases such as common colds).
- Participants with lower respiratory tract diseases different from asthma as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.
- Breastfeeding or pregnant women.
- Participants who are immediate family members of the investigator.
- Concurrent participation in other clinical trials or previous participation within 30 days prior to the first screening visit (S1).
- Participants with history of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
- Participants expected to have marked changes (e.g., moving) in the circumstances of life during the study.
- Participants who plan to start using anti-mite bedding or similar equipment during the study.
- Participants who are considered inappropriate for the study, according to the investigator criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Nueve de Julio, Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- Beijing, Beijing Municipality, China
- Guangzhou, Guangzhou, China
- Zhongshan, Guangzhou, China
- Xiangya, Hunan, China
- Changzhou, Jiangsu, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Tongji, Wuhan, China
- Huangzhou, China
- Porto, Portugal
- Santarém, Portugal
- Benidorm, Alicante, Spain
- Alicante, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nueve de Julio, Buenos Aires, Argentina; Rosario, Santa Fe Province, Argentina; Buenos Aires, Argentina; Beijing, Beijing Municipality, China; Guangzhou, Guangzhou, China; Zhongshan, Guangzhou, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.