Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2009 |
| End Date: | December 2015 |
| Contact: | Janice E Drake, CRTT |
| Email: | janice.drake@osumc.edu |
| Phone: | 800-678-6495 |
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.
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.
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.
Inclusion Criteria:
- Diagnosis of asthma
Exclusion Criteria:
- 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
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