Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 26, 2014
Last verified: June 2014

February 4, 2009
June 26, 2014
February 2009
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00837395 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma
Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood

Non-Probability Sample

primary care clinic, community sample

Asthma
Not Provided
premenstual asthma
women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Janice E Drake, CRTT 800-678-6495 janice.drake@osumc.edu
Contact: Sharon T Cheung, BS 614-293-4978 sharon.cheung@osumc.edu
United States
 
NCT00837395
2008H0292
No
Jennifer McCallister MD, Ohio State University
Ohio State University
Not Provided
Principal Investigator: Jennifer McCallister, MD Ohio State University
Ohio State University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP