Efficacy of Addition of High-volume Nasal Wash With Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis: Double, Randomized, Controlled Double Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the improvement in the Nasal Polyp Score
研究概览
简要总结
This is a double-blind, randomized, double-blind, randomized, double-blind, randomized block design with two intervention groups of 30 patients each. Patients not recruited at the otorhinolaryngology outpatient clinic of the Regional University Hospital of the North of Paraná and the University Hospital Specialties Ambulatory will be included in the study of chronic rhinosinusitis with polyposis are randomly divided with stratification for the presence of two groups of patients. 30 patients, with 9 asthmatics in each). Of the nasal nasal with 2mg budesonide diluted in high daily volume added to the corticosteroid injectable injectable and the topic for 16 weeks compared to placebo. The Polyp Score (NPS), Sono-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Olfactory Identification Test (UPSIT), peak nasal inspiratory flow (PNIF), visual scales preoperative tomography, acoustic rhinometry, computerized rhinomanometry and nasal endoscopy before and after the treatments. Position Paper on Nasal Rhinosinusitis and Nasal Polyps 2012; A bilateral nasal pole score is 5 and a maximum of 8 for both nostrils (with less than a score of 2 for each nostril).
详细描述
INTRODUTION: According to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012, chronic rhinosinusitis in adults can be defined as an inflammation of the nasal mucosa and paranasal sinuses lasting 12 weeks or more , associated or not with nasal polyposis. As to the origin of the polyps, these are typically related to the eosinophilic inflammation of the upper airways and result in obstructions in different degrees of the nasal cavities. Maximum clinical treatment - a combination of several classes of drugs to optimize therapy - often proves to be the first choice in the management of this disease. There is, however, no consensus on the composition or duration of maximal clinical treatment, and success rates are extremely variable. If there is no improvement in the condition, surgical treatment is usually instituted and, if necessary, supplemented with topical post-operative treatment. Recent studies have led to the perception that sprays and aerosols can not adequately reach the paranasal sinuses resulting in a better effect of the medication, if possible, such methods should be replaced by nasal cavity lavages using high volume solutions. OBJECTIVES: The present study aims to compare, through validated tests, the impact of the inclusion of nasal lavage with budesonide diluted in high volume in relation to placebo, in the improvement of the symptoms, signs, and quality of life of patients with chronic rhinosinusitis with polyposis. If effective, this therapy may decrease surgical indications and, consequently, health expenditures for the government. METHODOLOGY: Parallel, randomized, placebo-controlled, parallel type clinical trial. Patients with chronic rhinosinusitis with polyposis will be divided randomly with stratification for the presence of asthma in two groups (two blocks of 30 patients, 9 asthmatics each). It will evaluate the effectiveness of nasal lavage with 2mg budesonide diluted in high volume daily added to the initial systemic corticosteroid injectable and the topic for 16 weeks compared to placebo. EXPECTED RESULTS: It is expected that diluted budesonide improvement in the symptoms, signs, and quality of life of patients with chronic rhinosinusitis with polyposis.
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
- Double (Participant, Investigator)
盲法说明
This is a double-blind study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A minimum nasal polyp score (NPS) of 5 of a maximum of 8 for both nostrils (with at least a score of 2 for each nostril).
- •Presence of at least two of the following symptoms prior to screening: nasal blockage / obstruction / congestion or rhinorrhea (anterior or posterior); facial / pressure pain; reduction or loss of smell.
排除标准
- •A patient under the age of 18, or over 55;
- •SNOT-22 with sum of less than 7;
- •Patients who have used drugs or therapies that interfere with the results of this clinical trial within 2 months prior to screening: treatment with immunosuppressants; anti-immunoglobulin and within two months prior to screening.
- •Initiation of allergen immunotherapy within 3 months prior to first consultation or plan to initiate therapy during the screening period or randomized treatment period;
- •Patients who underwent any nasal surgery;
- •Patients on anti-leukotrienes and antihistamines
- •Asthmatic patients will be excluded if: forced expiratory volume (FEV1) is 60% predicted or lower; an exacerbation requiring systemic (oral and / or parenteral) or hospitalization for more than 24 hours for the treatment of asthma has occurred within 3 months prior to screening; use of a dose greater than 1000 μg of inhaled fluticasone or equivalent;
- •Patients with a short life expectancy (less than 6 months);
研究组 & 干预措施
Maximum clinical treatment + Budesonide diluted
The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril.
In this study, the investigator wishes to add to the maximum clinical treatment a daily wash with high volume diluted budesonide.
干预措施: Budesonide Nasal (Drug)
Maximum clinical treatment + Placebo
To compare the efficacy of adding diluted budesonide lavage to maximal clinical treatment, the placebo group is used. The placebo formula is composed of 1% glycerin diluted in water.
干预措施: Placebos (Drug)
结局指标
主要结局
Evaluate the improvement in the Nasal Polyp Score
时间窗: 16 weeks
To verify, from the change in the Nasal Polyp Score (NPS, range from 0 to 8, higher score indicates larger polyp size), the impact of maximum clinical treatment - intramuscular injection of Dispropan in intramuscular injectable suspension and budesonide in nasal spray, two sprays of 50 mcg in each nostril - plus high-volume diluted budesonide nasal lavage, compared to the same maximum clinical treatment plus high-flow placebo nasal lavage in patients with chronic rhinosinusitis with polyposis without previous nasal surgery for a period of 16 weeks.
次要结局
- Improves olfactory ability through the University of Pennsylvania Smell Identification Test(16 weeks)
- Sino-Nasal Outcome Test - 22 (SNOT-22)(16 weeks)
- Analogic visual scale (VAS)(16 weeks)
研究者
Marco Aurélio Fornazieri
Principal Investigator
Universidade Estadual de Londrina