MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED, CLINICAL STUDY TO DEMONSTRATE THE THERAPEUTIC CLINICAL EQUIVALENCE OF TWO MOMETASONE NASAL SPRAYS IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).
研究概览
简要总结
Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).
详细描述
Perennial allergic rhinitis may be defined clinically as an inflammatory condition of the nose characterised by nasal obstruction, sneezing, itching, or rhinorrhoea. It occurs due to an exaggerated response to an environmental trigger which results in inflammation of the lining of the nose; it is similar to hayfever, however, the substances which cause the allergic reaction are present all year round; common causes include the faecal matter of the house dust-mite (Dermatophagoides pteronyssinus), animal proteins from domestic pets (saliva or skin proteins), and industrial dusts and fumes In those with perennial rhinitis, cigarette smoke, washing powders, detergents, strong perfume, and traffic fumes may exacerbate the condition.
According with WAO (World Allergy Organization), perennial rhinitis predominates in South America, Asia, Africa and Australia; perennial and seasonal rhinitis occur commonly in the U.S.A. and Japan. Seasonal rhinitis predominates in Europe. In one study in London of adults between the ages of 16 and 65 years, in 1991 the prevalence of rhinitis was 16%; of these, 8% had perennial symptoms, 6% perennial and seasonal symptoms, and 2% seasonal symptoms alone. As with asthma, both seasonal and perennial rhinitis seem to be increasing. The 2004-05 National Health Survey stated that 3.2 million Australians (approximately 16.1% of the population) self-reported experiencing symptoms of hay-fever and perennial rhinitis. The prevalence was found to be highest amongst those aged 25-34 and was slightly higher among females (1.7 million) than males (1.5 million).
Perennial allergic rhinitis (PAR) as seasonal allergic rhinitis (SAR) result from an immunological response mediated by IgE; there is also a Th2 cell component accounting for chronic symptoms. Histamine is a well-known mediator responsible for the signs and symptoms of SAR but many other mediators including leukotrienes and prostaglandin D2 are involved.
The management of perennial rhinitis involves the avoidance of triggers such as house dust-mite faeces and animal proteins, in conjunction with pharmacological treatments as:
Corticosteroids as Budesonide, Mometasone furoate, in the form of a nasal spray are the first-line treatment for perennial allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, 12 years until 65 years old. Subjects with a minimum of 2 years of previous history of perennial allergic rhinitis to at least one perennial allergen at the time the study is being conducted.
- •Signed informed consent form. For patients under the age of majority the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form.
- •Subjects with perennial allergic rhinitis documented in writing positive allergic skin (a wheal >3mm) test or positive RAST test, performed at screening or within the past 12 months.
- •A score of at least 6 on the TNSS with a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms.
- •Subjects capable of recording nasal allergy diary every day.
排除标准
- •Females who are pregnant, lactating or plan to get pregnant during the study. History of asthma over the previous two years that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
- •Patients with some nasal conditions (i.e. infectious sinusitis, hypertrophic rhinitis), or with clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
- •Upper respiratory tract infection or any untreated systemic infections within the previous 30 days.
- •Patients previously treated with mometasone within the previous 30 days Patients who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous 2 years or are still receiving this kind of therapy.
- •Patients with a history of tuberculosis. Patients with glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection.
- •The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox or measles.
- •Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
- •Planned travel outside of the local area for more than 2 consecutive days or 3 days in total.
- •The patient has a history of alcohol or drug abuse.
研究组 & 干预措施
Mometasone
Mometasone, nasal spray for 8 weeks, 2 actuations each nostril in the morning.
干预措施: Mometasone furoate (Drug)
Nasonex®
Nasonex nasal spray for 8 weeks 2 actuations each nostril in the morning.
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).
时间窗: 8 weeks
次要结局
- Safety monitoring AE, routine laboratory haematology, biochemical tests, urinalysis, assessment of adrenal function to be sure of lack of systemic effect of nasal spray formulation Overall Patient's and Physician's global assessment.(8 weeks)