Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness and reversible airway obstruction. Over the last decade, the prevalence of asthma is on the rise and it disproportionately affects more women than men. As much as 40% of women with asthma are known to have worsening of asthma symptoms and lung function prior to menstruation. This syndrome is being increasingly recognized as premenstrual asthma (PMA). The pathologic differences in female asthmatics with and without this syndrome are not known. The evidence regarding the role of sex hormones has been contradicting. We propose an observational cohort study to examine the changes in airway inflammation in women with asthma in relation to their menstrual cycle and their association with sex hormone levels. In addition we will include women on oral contraceptives to determine their effect on airway inflammation and asthma symptoms.
We hypothesis that:
Recruited subjects will be asked to record asthma symptom scores, morning Peak Expiratory Flow Rate (m-PEFR) and rescue asthma medication (β2-agonist) used daily during the one month screening period to identify women with and without pre-menstrual asthma. Asthmatic women with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and luteal phase (days 21-24) and women on oral contraceptive pills (OCP) will be evaluated on days 9-12 of their OCP cycle and during the days 25-28, off of OCP consecutively for a 2-month period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Women with pre-menstrual asthma (PMA): As defined by a 20% or more fall in PEFR and / or change by 20% or more of daily symptom score. | ||
| 2 | Women without pre-menstrual asthma | ||
| 3 | Women on oral contraceptives |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate menstrual-related changes in airway inflammation of asthma patients with and without premenstrual worsening of symptoms. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of sex hormones in airway inflammation | 3 months | |
| To examine the effect of oral contraceptive pills on airway inflammation | 3 months | |
| To assess the cyclical changes in airway inflammation as measured by -Fractional exhaled Nitric Oxide (FeNO), -Exhaled Breath Condensate (EBC) pH and -Serum eosinophil cationic protein (ECP), in asthmatic women with and without premenstrual asthma. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Females diagnosed with asthma, with either regular menstral cycles or on monophasic oral contraceptives, with or without pre-mentstual asthma symptoms
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anandhi T Murugan, MD, MPH | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum Eosinophil Cationic Protein (ECP) samples will be obtained. The 5ml blood samples for measuring ECP levels will be collected in silica gel-containing tubes. After centrifuging, the supernatant will be frozen and ECP levels will bemeasured using an ELISA kit
| 3 months |
| To analyze the association of between serum estradiol and progesterone levels and the variation in airway inflammation, airflow limitation and asthma symptoms | 3 months |
| To study the effect of oral contraceptives on airway inflammation by measuring serum and exhaled inflammatory indices | 3 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |