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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: Completed study of Asthma, sponsored by The University of Texas Medical Branch, Galveston.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 6 participants
Start Date 2007-09
Est. Completion 2010-02

What the finished NCT00584441 record still lists

NCT00584441 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (100% lower).

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 0 interventions.

NCT00584441 reports a single indexed study location in 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.

Similar trials for Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00584441's enrollment target sits among peer trials

6 372nd of 374 higher than 1 of 374 other Asthma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00584441, the US trial registry maintained by the National Library of Medicine. NCT00584441 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.