Demonstration of therapeutic equivalence/non-inferiority as well as early onset of action of the novel water-soluble budesonide nasal spray (Budesolv) compared with marketed Rhinocort® aqua 64 in patients suffering from grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma.

Marinomed Biotech AG0 个研究点目标入组 84 人2018年6月14日

适应症Allergic Rhinitis/ Rhinoconjunctivitis MedDRA version: 20.0Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0Level: LLTClassification code 10019170Term: Hay feverSystem Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1Level: PTClassification code 10048908Term: Seasonal allergySystem Organ Class: 10021428 - Immune system disorders Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Allergic Rhinitis/ Rhinoconjunctivitis
发起方: Marinomed Biotech AG
入组人数: 84
状态: 进行中（未招募）
最后更新: 6年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2018年6月14日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Marinomed Biotech AG

入排标准

入选标准

•I1\.Written informed consent obtained before any trial related procedures are performed
•I2\.Healthy male or female subjects aged 18 years or older
•I3\.Female subjects of child\-bearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive
•methods until the end of treatment visit
•I4\.A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
•I5\.Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12\) using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of nasal congestion”, rhinorrhea”, itchy nose” and sneezing”, each of which have been scored on a categorical scale from 0 to 3\.
•I6\.Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 6 months prior to study start.
•I7\.Positive serum specific IgE against recombinant major allergen components of the used grass pollen (specific CAP IgE \=0\.70 kU/L) at screening or within the last 6 months prior to study start.
•I8\.Patients with a body weight of \= 50kg and a body mass index within the range of 19\-30kg/m2\.
•I9\.Non\-smoking subjects (smoked \<10 packs years in their lifetime and had not smoked in the last 6 months)

排除标准

•E1Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test).
•E2A clinical history of uncontrolled asthma within 3 months prior to screening.
•E3Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator.
•E4Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross\-reacting allergen within the past 3 years.
•E5Ongoing treatment with any allergen\-specific immunotherapy product.
•E6Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study.
•E7Subjects with history of tuberculosis.
•E8Subjects with any fungal/viral/bacterial respiratory or systemic infections during the last 30 days.
•E9Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization.
•E10Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator.