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临床试验/NCT00837395
NCT00837395终止不适用

Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma

Ohio State University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
1
主要终点
To determine the patterns of serum microRNA in asthmatic women with premenstrual asthma and asthmatic women without premenstrual asthma at baseline and during the premenstrual period

研究概览

简要总结

A small number of women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period. This study is being done to investigate the possible causes of this premenstrual increase in asthma symptoms and to help asthma care providers identify those patients who may suffer from this condition.

详细描述

It is well established that women suffer more asthma symptoms and worse health-related quality of life than men with the same level of asthma severity. The etiology for these sex-related differences in unknown, but a subset of women has premenstrual asthma (PMA) with worsening of their asthma symptoms either prior to or during menstruation. Previous small trials have suggested that an increase in the host inflammatory response may correlate with PMA symptoms. We have evidence that small inhibitory ribonucleic acids, microRNAs, circulating in the peripheral blood of human patients may be expressed in different patterns in certain disease states when compared to healthy individuals.

We plan to compare the patterns of microRNA expression in a well characterized group of women with PMA to those without PMA to determine if alterations in these microRNA patterns play a role in increased asthma symptoms in the premenstrual period. In addition, we plan to compare the levels of inflammatory markers in these populations to better define the specific subset of women that may be at risk for premenstrual asthma. By better characterizing these women, we hope to identify clinically relevant predictors that may guide therapy for women who suffer from PMA.

Procedures to be used in this study include questionnaire administration, pulmonary function assessment, exhaled nitric oxide evaluation, urine sampling for pregnancy, and blood draws for microRNA and serum leukotriene evaluation. These techniques are utilized widely in clinical asthma research, and are associated with minimal risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Diagnosis of asthma

排除标准

  • Are pregnant
  • Take hormonal medication
  • Have an illness with fever (> 38.0 ˚ C or 100.4 ˚ F) within 24 hours of Visit 1 or between Visits 1 and 2
  • Are participating in another interventional research trial
  • Have other major chronic illnesses that would interfere with participation
  • Are taking the following medications: leukotriene receptor antagonists, oral steroids, anticoagulants, or insulin
  • Are unable to provide consent

结局指标

主要结局

To determine the patterns of serum microRNA in asthmatic women with premenstrual asthma and asthmatic women without premenstrual asthma at baseline and during the premenstrual period

时间窗: during the study

microRNA patterns in women with premenstrual asthma

次要结局

  • To determine the level of exhaled nitric oxide and serum leukotrienes B4 (LTB4) and C4 (LTC4) in asthmatic women with premenstrual asthma and asthmatic women without premenstrual asthma at baseline and during the premenstrual period(during the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer McCallister MD

Associate Professor Clinical Internal Medicine

Ohio State University

研究点 (1)

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