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临床试验/NCT03879590
NCT03879590Unknown3 期

Efficacy Of Doxophylline As A Sparing Treatment For Inhaled Corticosteroids In Mexican Children With Asthma

Universidad Autonoma de Nuevo Leon0 个研究点目标入组 60 人开始时间: 2019年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
60
主要终点
Changes in the values of the forced expiratory volume on the first second

研究概览

简要总结

This study evaluated the efficacy of doxophylline as a steroid sparing treatment in Mexican children with asthma treated with medium ir high doses of inhaled corticosteroids (ICS). It is a cross over study in which both groups of patients will receive doxophylline plus a lower steroid dose maintaining the same treatment step according to GINA guidelines, one group will maintain the same treatment dose while the other will start with doxophylline with the lower ICS dose, and by the middle of the study both groups will interchange treatment schemes.

详细描述

Inhaled corticosteroids (ICS) are first-line drugs for the treatment of persistent asthma. The effectiveness of existing ICS is excellent; however, a number of questions remain regarding its possible adverse effects, despite the fact that the use of the inhalation route has allowed the minimization of the systemic exposure to these drugs. Methylxanthines are widely used in the treatment of asthma. It is one of the few medications for asthma that can be administered orally. They are useful especially in patients who cannot adapt to inhaled medications. Methylxanthines are unique in exhibiting dual-function properties by inducing bronchodilation and having anti-inflammatory and immunomodulatory effects. Theophylline is the oldest methylxanthine and non-specifically inhibits phosphodiesterase, it is a little used drug because it has many adverse effects with lower therapeutic index. Doxophylline is a drug of the family of methylxanthines, with a similar efficacy compared to theophylline when applied in the treatment of various respiratory diseases, but with better tolerability profile. Doxophylline has been shown to be a bronchodilator and anti-inflammatory drug with a wider therapeutic window than other methylxanthines. Clinical studies have reported that doxophylline is more effective in improving lung function tests in adults and children, as well as in decreasing clinical symptoms, reducing the incidence of adverse effects and the need of emergency bronchodilators, with a better profile in terms of safety and it has been demonstrated that doxophylline potentially reduces the need for corticosteroids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Mexican patients between 6 and 16 years old.
  • Clinical diagnosis of asthma according to the current guidelines of the Global Asthma Initiative (GINA)
  • Patients with asthma treated with budesonide at medium or high doses during (GINA guidelines´ steps 3 or 4) at least two months before the first study visit. Budesonide medium dose: 200-400 mcg / day (6-11 years) and 400-800 mcg / day (> 12 years). Budesonide high dose: > 400 mcg / day (6-11 years) and > 800 mcg / day (> 12 years).

排除标准

  • Patients <6 or ≥16 years of age.
  • Patients with <16 kg of body weight.
  • Patients who have had an asthma exacerbation that required treatment with systemic corticosteroids (oral, intramuscular or intravenous) during the 2 months prior to the first study visit.
  • Patients who have presented an asthma exacerbation that required hospitalization during the 2 months prior to the first study visit.
  • Any other chronic lung disease that could impair lung function evaluation.
  • Cardiovascular, infectious, metabolic or neoplastic disease that could interfere with the evaluation of the patient.
  • Current use of drugs that interact with doxophylline: other xanthines, ephedrine or other sympathomimetics, erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, two months prior vaccination, propranolol, phenytoin or other anticonvulsants.

研究组 & 干预措施

Budesonide and Doxophylline

Experimental

Budesonide at the same dose in which the subject is currently treated (GINA step 3 or 4) plus doxophylline at a dose of 18 mg / kg per day

干预措施: Doxophylline (Drug)

Budesonide and Doxophylline

Experimental

Budesonide at the same dose in which the subject is currently treated (GINA step 3 or 4) plus doxophylline at a dose of 18 mg / kg per day

干预措施: Budesonide (Drug)

Low budesonide and Doxophylline

Active Comparator

Reduced dose of inhaled budesonide (GINA step down) plus doxophylline to a dose of 18 mg / kg per day, maximum of 800 mg / day (Group B)

干预措施: Doxophylline (Drug)

Low budesonide and Doxophylline

Active Comparator

Reduced dose of inhaled budesonide (GINA step down) plus doxophylline to a dose of 18 mg / kg per day, maximum of 800 mg / day (Group B)

干预措施: Budesonide (Drug)

结局指标

主要结局

Changes in the values of the forced expiratory volume on the first second

时间窗: 4 weeks

Changes in the values of FEV1 (FEV1 in percent predicted) by comparing the baseline to subsequent evaluations.

次要结局

  • Use of systemic corticosteroids(4 weeks)
  • Clinical asthma control assessment(4 weeks)
  • Changes on the exhaled breath temperature(4 weeks)
  • Asthma exacerbations(4 weeks)
  • Use of rescue therapy(4 weeks)

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Nora Gonzalez Diaz

Dra. med.

Universidad Autonoma de Nuevo Leon

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