Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma

This study is currently recruiting participants.
Verified November 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Jennifer McCallister MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT00837395
First received: February 4, 2009
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: during the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 25
Study Start Date: February 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
premenstual asthma
women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period

Detailed Description:

It is well established that women suffer more asthma symptoms and worse health-related quality of life than men with the same level of asthma severity. The etiology for these sex-related differences in unknown, but a subset of women has premenstrual asthma (PMA) with worsening of their asthma symptoms either prior to or during menstruation. Previous small trials have suggested that an increase in the host inflammatory response may correlate with PMA symptoms. We have evidence that small inhibitory ribonucleic acids, microRNAs, circulating in the peripheral blood of human patients may be expressed in different patterns in certain disease states when compared to healthy individuals.

We plan to compare the patterns of microRNA expression in a well characterized group of women with PMA to those without PMA to determine if alterations in these microRNA patterns play a role in increased asthma symptoms in the premenstrual period. In addition, we plan to compare the levels of inflammatory markers in these populations to better define the specific subset of women that may be at risk for premenstrual asthma. By better characterizing these women, we hope to identify clinically relevant predictors that may guide therapy for women who suffer from PMA.

Procedures to be used in this study include questionnaire administration, pulmonary function assessment, exhaled nitric oxide evaluation, urine sampling for pregnancy, and blood draws for microRNA and serum leukotriene evaluation. These techniques are utilized widely in clinical asthma research, and are associated with minimal risk.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

  • Diagnosis of asthma

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837395

Contacts
Contact: Janice E Drake, CRTT 800-678-6495 janice.drake@osumc.edu
Contact: Sharon T Cheung, BS 614-293-4978 sharon.cheung@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Jennifer McCallister, MD         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jennifer McCallister, MD Ohio State University
  More Information

No publications provided

Responsible Party: Jennifer McCallister MD, Jennifer McCallister, Ohio State University
ClinicalTrials.gov Identifier: NCT00837395     History of Changes
Other Study ID Numbers: 2008H0292
Study First Received: February 4, 2009
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
premenstrual increase in asthma symptoms

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014