Study Stopped
Co-investigator left the university and another co-investigator died several years ago, making it impossible to complete the study as planned.
Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma
1 other identifier
observational
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 28, 2020
April 1, 2020
10.8 years
February 4, 2009
April 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the patterns of serum microRNA in asthmatic women with premenstrual asthma and asthmatic women without premenstrual asthma at baseline and during the premenstrual period
microRNA patterns in women with premenstrual asthma
during the study
Secondary Outcomes (1)
To determine the level of exhaled nitric oxide and serum leukotrienes B4 (LTB4) and C4 (LTC4) in asthmatic women with premenstrual asthma and asthmatic women without premenstrual asthma at baseline and during the premenstrual period
during the study
Study Arms (1)
premenstual asthma
women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period
Eligibility Criteria
primary care clinic, community sample
You may qualify if:
- Diagnosis of asthma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer McCallister, MD
Ohio State University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Clinical Internal Medicine
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 28, 2020
Record last verified: 2020-04