Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma
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|ClinicalTrials.gov Identifier: NCT00837395|
Recruitment Status : Terminated (Co-investigator left the university and another co-investigator died several years ago, making it impossible to complete the study as planned.)
First Posted : February 5, 2009
Last Update Posted : April 28, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period
- 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 [ Time Frame: during the study ]microRNA patterns in women with premenstrual asthma
- 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 [ Time Frame: during the study ]Inflammatory markers
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837395
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Jennifer McCallister, MD||Ohio State University|