Menstrual Differences in Airway Inflammation in Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00584441
First received: December 20, 2007
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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 for a 2-month period.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Menstrual Differences in Airway Inflammation in Asthma

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • To evaluate menstrual-related changes in airway inflammation of asthma patients with and without premenstrual worsening of symptoms. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect of sex hormones in airway inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To examine the effect of oral contraceptive pills on airway inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To assess the cyclical changes in airway inflammation as measured by -Fractional exhaled Nitric Oxide (FeNO), -Exhaled Breath Condensate (EBC) pH and -Serum eosinophil cationic protein (ECP), in asthmatic women with and without premenstrual asthma. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To analyze the association of between serum estradiol and progesterone levels and the variation in airway inflammation, airflow limitation and asthma symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To study the effect of oral contraceptives on airway inflammation by measuring serum and exhaled inflammatory indices [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum Eosinophil Cationic Protein (ECP) samples will be obtained. The 5ml blood samples for measuring ECP levels will be collected in silica gel-containing tubes. After centrifuging, the supernatant will be frozen and ECP levels will bemeasured using an ELISA kit


Enrollment: 6
Study Start Date: September 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with pre-menstrual asthma (PMA): As defined by a 20% or more fall in PEFR and / or change by 20% or more of daily symptom score.
2
Women without pre-menstrual asthma
3
Women on oral contraceptives

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Females diagnosed with asthma, with either regular menstral cycles or on monophasic oral contraceptives, with or without pre-mentstual asthma symptoms

Criteria

Inclusion Criteria:

  • With diagnosis of Asthma (ICD-9 Code 493)
  • Requiring low to moderate dose inhaled corticosteroids for control.
  • With Pre-bronchodilator FEV1 ≥50% and ≤90% of predicted normal
  • With a positive bronchodilator response
  • Non smoker or Ex-smoker (Quit >1 year ago)
  • Regular menstrual cycle (24-35 days cycle)
  • With and without OCP use
  • Constant dose of asthma maintenance medication for at least 30 days prior to enrolment

Exclusion Criteria:

  • Recent use of systemic steroids (<30 days)
  • Severe Asthma (FEV1 <50% or frequent exacerbations or systemic steroid dependence)
  • Negative bronchodilator response
  • Current Smoker
  • Irregular Menses or postmenopausal
  • Positive pregnancy test
  • Use of hormonal contraceptives other than monophasic OCPs
  • Exacerbation or Respiratory Infection or antibiotic use within the last 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584441

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Anandhi T Murugan, MD, MPH University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00584441     History of Changes
Other Study ID Numbers: 07-256
Study First Received: December 20, 2007
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014