A Randomised, Double-blind, Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008
研究概览
简要总结
This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).
详细描述
This trial was conducted as a multi-centre, randomised, double-blind, parallel-group, placebo-controlled phase III trial, assessing the efficacy of SLITone Dermatophagoides mix in adults (18-65 years). 5 centres in Spain participated.
Subjects with house dust mite allergic asthma were randomised to receive either SLITone Dermatophagoides mix (active) or placebo treatment (1:1) for approximately 1 year. The trial duration was extended to 2 years. Administration was done sublingually (under the tongue) once daily preferably in the morning. A monodose container comprised the daily dose of 200 STU.
Subjects were kept in asthma control during the entire trial (2 years). Except for during 2 evaluation periods of 2 months in autumn 2007 and autumn 2008, subjects used the medications prescribed by their physician. During the 2 evaluation periods of 2 months in autumn 2007 and autumn 2008, subjects used provided and standardised rhinoconjunctivitis and asthma medications. The asthma medication use was to reflect the subject's asthma status. This was done by treatment with a low maintenance dose of control medication supplemented with rescue medication as needed.
Rhinoconjunctivitis medication during the 2 evaluation periods in autumn 2007 and autumn 2008; to standardise the medication used to relieve rhinoconjunctivitis symptoms, subjects were provided with the following free medications as needed:
- Desloratadine tablet (5 mg per tablet; anti-histamine; Aerus®)
- Budesonide nasal spray (64 µg per puff; inhaled corticosteroid)
- Prednisone tablet (5 mg per tablet; oral corticosteroid)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical history of house dust mite induced persistent mild to moderate. asthma, with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution.
- •Demonstration of a positive specific serum IgE test to Dermatophagoides during the year prior to the screening visit (CAP Class 2 or higher or equivalent).
- •Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix.
- •If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test.
- •Willingness to comply with this protocol.
排除标准
- •FEV1 < 70% of predicted value with appropriate medication.
- •Asthma controlled at randomization without need of inhaled corticosteroids or with a dose higher than 1000 µg/day of beclometasone or equivalent.
- •A clinical history of symptomatic perennial allergic asthma caused by allergens to which the subjects is regularly exposed (Alternaria, cat), other than house dust mites.
- •Chronic sinusitis.
- •Aspirin or sulfite intolerance.
- •Chronic obstructive pulmonary disease.
- •Current severe atopic dermatitis.
- •Severe asthma.
- •Use of an investigational drug within 30 days prior to screening.
- •Previous immunotherapy with house dust mite allergens for at least 2 years within the previous 10 years.
- •At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (se-rous otitis media is not an exclusion criterion).
- •Physical examination with clinically relevant findings.
- •Any of the following underlying conditions known or suspected to be present: Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alco-holism, ischaemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other ma-jor systemic disease).
- •Immunosuppressive treatment.
- •A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
- •Unlikely to be able to complete the trial.
- •Unwillingness to comply with trial protocol regimen for asthma and/or rhinoconjunctivitis medication.
研究组 & 干预措施
Active
SLITone Dermatophagoides Mix
干预措施: SLITone(TM) Dermatophagoides mix (Biological)
Active
SLITone Dermatophagoides Mix
干预措施: Salbutamol inhaler (Drug)
Active
SLITone Dermatophagoides Mix
干预措施: Budesonide/formoterol inhaler (Drug)
Active
SLITone Dermatophagoides Mix
干预措施: Prednisone tablet (Drug)
Active
SLITone Dermatophagoides Mix
干预措施: Desloratadine tablet (Drug)
Active
SLITone Dermatophagoides Mix
干预措施: Budesonide nasal spray (Drug)
Placebo
SLITone Placebo
干预措施: Placebo (Biological)
Placebo
SLITone Placebo
干预措施: Salbutamol inhaler (Drug)
Placebo
SLITone Placebo
干预措施: Budesonide/formoterol inhaler (Drug)
Placebo
SLITone Placebo
干预措施: Prednisone tablet (Drug)
Placebo
SLITone Placebo
干预措施: Desloratadine tablet (Drug)
Placebo
SLITone Placebo
干预措施: Budesonide nasal spray (Drug)
结局指标
主要结局
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008
时间窗: 8 weeks
Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40. The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).
次要结局
- Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007(8 weeks)
- Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008(8 weeks)
- Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008(8 weeks)
- Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007(8 weeks)