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临床试验/NCT02620956
NCT02620956已完成2 期

Aerosol Deposition in Asthmatic Obese Women Using Heliox: A Randomized, Crossover, Controlled Clinical Trial Study

Jacqueline de Melo Barcelar2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Aerosol deposition in pulmonary compartments

研究概览

简要总结

BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler.

详细描述

BACKGROUND: Obese asthmatics are difficult to treat effectively, worse asthma control, and do not respond as well to standard therapy as lean asthmatic. Medical aerosols an important route of drug delivery in asthma, but narrowing in the airway cause by the obesity, can provoke turbulence and the effectiveness of the treatment could be compromise.

AIM: To assess pulmonary deposition, distribution of radio-aerosol and analyze upper way dimension in obese and normal weight women, using 2-D planar scintigraphyand and computed tomography. METHODS: 20 obese women, 10 asthmatics and 10 non-asthmatics took part of the first part of the study. Anthropometric and clinical assessments were carried out, than lung function was performed. After randomization of the sequence of gas (sequence 1- oxygen and heliox; sequence 2-heliox and heliox) that would be used to inhale an aerosol with technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler. All patients inhaled two times with one week of washout between then to eliminate risk of residual trace radiation and to avoid the possibility of bias.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Were women with Body mass Index (BMI) ≥30kg/m2 for obese and BMI =18.5 - 24.9 kg/m2 for the control group
  • Age between 18 to 60 years old
  • With and without moderate to severe asthma
  • Positive response to bronchodilator (improvement in FEV1 and/or FVC of at least 12% and 200ml).

排除标准

  • Were women with active pulmonary disease other than asthma
  • Neuromuscular diseases
  • Smokers and those incapable of performing procedures were excluded.

结局指标

主要结局

Aerosol deposition in pulmonary compartments

时间窗: two days

次要结局

  • Aerosol deposition in vertical and horizontal gradient(two days)

研究者

发起方
Jacqueline de Melo Barcelar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jacqueline de Melo Barcelar

principal investigator

Universidade Federal de Pernambuco

研究点 (2)

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