An observational study in Asthma, sponsored by Ohio State University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by Ohio State University · Observational
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 24 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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primary care clinic, community sample
Exclusion Criteria:
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
microRNA patterns in women with premenstrual asthma
Time frame: during the study
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
Inflammatory markers
Time frame: during the study
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Ohio State University