Standardized Phleum pratense in TBU/ml in liquid formulation for sublingual immunotherapy: Phase II, randomized dose determination clinical trial. DEDO-G Study.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 15
- 主要终点
- The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a portable nasal inspiratory flow meter provided by the Sponsor, and the test will be considered positive if the reduction in NIPF is ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptoms on a scoring scale with a maximum of 13 points.
研究概览
简要总结
To determine the most effective dose of the allergen extract of grass polen (Phleum pratense), for immunotherapeutic treatment administered via sublingual route, standardized in TBU/mL, without compromising patient safety.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 12 and 50 years
- •Diagnosis of allergic rhinitis with/without conjunctivitis, with/without associated asthma. In patients with associated asthma at the time of recruitment, lung function must be FEV1 > 70% of predicted and FVC > 80% of predicted
- •Positive skin prick test to *Phleum pratense* using the extracts supplied by the Sponsor.
- •Centrally performed determination of Phleum pratense-specific IgE ≥ 0.70 kU/L.
- •Positive nasal provocation test result obtained with a maximum concentration of 1/10
- •Signed informed consent to participate in the study
- •In women of childbearing potential (considered fertile from menarche to post-menopause unless sterilized due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), certainty of not being pregnant at study entry, which will be confirmed by a negative urine pregnancy test. In addition, a new pregnancy test must be performed at the end of treatment to confirm absence of pregnancy
- •No prior specific immunotherapy with Phleum pratense extracts or any related pollen within the last 5 years, and not receiving concomitant specific immunotherapy with Phleum pratense or any other allergen during the study period
排除标准
- •Sensitization (skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites, or any other allergenic source depending on each participating site’s geographic location) that may interfere with the patient’s clinical evolution during follow-up. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid. In the case of sensitization to animal dander, inclusion may be accepted provided that the patient has no habitual contact with such animals and that there is no possibility of this occurring during follow-up. Sensitization to pollens that overlap the grass season will not be considered an exclusion criterion, except when there is concomitant sensitization to Cupressus arizonica, ash, plane tree, and/or oak (considering results from the last 6 months or from the prick test performed in the study with supplied allergens) whose pollen seasons occur during the patient follow-up period
- •Nasal hyperreactivity, defined as a non-specific response whereby the negative control induces a reaction corresponding to ≥50% of the positive response observed during the nasal provocation test.
- •Recent nasal/oral surgery (within 6 months or less; in the case of dental extractions, dental implants, or similar procedures, within the last 2 months).
- •Nasal septum perforation
- •Partially controlled or uncontrolled bronchial asthma according to GINA criteria, including subjects with FEV1 ≤ 70% of predicted, FVC ≤ 80% of predicted, and receiving any asthma treatment other than short-acting β2-adrenergic bronchodilators (SABAs) used as rescue medication.
- •Usual contraindications for allergen immunotherapy: Active or controlled neoplastic disease diagnosed within the last 5 years, Acute psychiatric pathology limiting the patient’s normal daily activity, Pregnancy and lactation
- •Chronic use of medication that prevents adequate analysis and follow-up during the study: antihistamines, oral, inhaled and/or parenteral corticosteroids, membrane stabilizers (cromoglycates), antidepressants
- •Refusal to participate in the trial and to sign informed consent
- •Known allergy to components of the investigational product other than the study allergen
研究组 & 干预措施
Test de provocación nasal Phleum pratense
干预措施: Test de provocación nasal Phleum pratense (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a portable nasal inspiratory flow meter provided by the Sponsor, and the test will be considered positive if the reduction in NIPF is ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptoms on a scoring scale with a maximum of 13 points.
The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a portable nasal inspiratory flow meter provided by the Sponsor, and the test will be considered positive if the reduction in NIPF is ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptoms on a scoring scale with a maximum of 13 points.
The individual response of each recruited subject to the Nasal Provocation Test (NPT). NPT response will be assessed using objective and subjective parameters. Objective assessment will be based on changes in Nasal Inspiratory Peak Flow (NIPF), while subjective assessment will be based on the Total Nasal Symptom Score (TNSS, 0–12). NPT positivity will be determined according to protocol-defined criteria.
The individual response of each recruited subject to the Nasal Provocation Test (NPT). NPT response will be assessed using objective and subjective parameters. Objective assessment will be based on changes in Nasal Inspiratory Peak Flow (NIPF), while subjective assessment will be based on the Total Nasal Symptom Score (TNSS, 0–12). NPT positivity will be determined according to protocol-defined criteria.
次要结局
- Determination of systemic and/or local adverse reactions associated with the trial, particularly those related to investigational product/placebo, and those due to the nasal provocation test or skin prick test.
- Rescue medication used throughout the study in relation to the investigational product/placebo (this does not include any rescue medication that may be administered after the nasal provocation test or skin prick test).
- Laboratory determinations of serum markers at baseline and end of study: Specific IgE to Phleum pratense and major allergens rPhl p1 + rPhl p5b., y Phleum pratense IgG4.
- Phleum pratense skin prick test at baseline and end of study for comparative analysis
- Independent analysis of each of the clinical variables included in the nasal provocation test scoring scale
研究者
Carmen Santos -actuando en nombre del Promotor
Scientific
Asac Pharmaceutical Inmunology S.A.