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NCT00584441 · ClinicalTrials.gov registry record
Menstrual Differences in Airway Inflammation in Asthma
A clinical trial of Asthma, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- 6
- Enrollment target
- 1
- Study location
NCT00584441 is a study of Asthma that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 6 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00584441, a study of Asthma, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Study Locations (1)
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-02 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00584441
The ClinicalTrials.gov registry entry for NCT00584441 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (100% lower). The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 0 interventions.
NCT00584441 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00584441 about?
NCT00584441 is a clinical study titled "Menstrual Differences in Airway Inflammation in Asthma". 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 wor...
What is the current status of trial NCT00584441?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2007-09. Estimated completion is 2010-02.
What conditions does trial NCT00584441 study?
This clinical trial studies the following conditions: Asthma.
Who is sponsoring clinical trial NCT00584441?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00584441 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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