Menstrual Differences in Airway Inflammation in Asthma
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|ClinicalTrials.gov Identifier: NCT00584441|
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : February 13, 2013
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:
- Women with premenstrual asthma will show increased indices of airway inflammation in various phases the monthly menstrual cycle.
- In women with premenstrual asthma, a change in serum estradiol/progesterone ratio during the late luteal phase is associated with worsening of airway inflammation, air flow limitation and asthma symptoms.
- The use of oral contraceptives is associated with suppression of the cyclical changes in airway inflammation due to lack of fluctuations in estradiol and progesterone levels.
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Observational Model:||Case Control|
|Official Title:||Menstrual Differences in Airway Inflammation in Asthma|
|Study Start Date :||September 2007|
|Primary Completion Date :||February 2010|
|Study Completion Date :||February 2010|
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.
Women without pre-menstrual asthma
Women on oral contraceptives
- To evaluate menstrual-related changes in airway inflammation of asthma patients with and without premenstrual worsening of symptoms. [ Time Frame: 3 months ]
- To examine the effect of sex hormones in airway inflammation [ Time Frame: 3 months ]
- To examine the effect of oral contraceptive pills on airway inflammation [ Time Frame: 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. [ Time Frame: 3 months ]
- To analyze the association of between serum estradiol and progesterone levels and the variation in airway inflammation, airflow limitation and asthma symptoms [ Time Frame: 3 months ]
- To study the effect of oral contraceptives on airway inflammation by measuring serum and exhaled inflammatory indices [ Time Frame: 3 months ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584441
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Anandhi T Murugan, MD, MPH||University of Texas|