Full Text View
Tabular View
No Study Results Posted
Related Studies
Oral Contraceptives and Asthma Control
This study is currently recruiting participants.
Verified by University of Kentucky, February 2009
First Received: April 15, 2008   Last Updated: February 20, 2009   History of Changes
Sponsors and Collaborators: University of Kentucky
American College of Allergy, Asthma and Immunology
Information provided by: University of Kentucky
ClinicalTrials.gov Identifier: NCT00662051
  Purpose

Asthma is a chronic inflammatory disorder of the airways affecting approximately 15 million individuals in the U.S. The rate of asthma exacerbations among women is twice that of men after adolescence, and a large proportion of females with asthma report worsened asthma symptoms during different phases of the menstrual cycle. Hormonal influences have been hypothesized to account for these differences. Decreased peak flow rates and increased symptoms have been found in females during the premenstrual phase of the menstrual cycle when estrogen and progesterone levels are low. Estrogen and progesterone have both been found to reduce smooth muscle contractility and increase bronchial smooth muscle relaxation. A perimenstrual shift toward a Th2 (allergic) phenotype characterized by a decreased interferon-gamma to interleukin-10 ratio has been demonstrated in healthy women not using oral contraceptives compared to midcycle; however, the effect was blunted in healthy oral contraceptive pill users, implying hormonal modulation of the allergic phenotype. Several case reports have demonstrated a therapeutic benefit of oral contraceptives in decreasing asthma exacerbations and corticosteroid requirements. Human studies have demonstrated that estrogen decreases pro-inflammatory cytokine generation, neutrophil recruitment, and inhibits inducible nitric oxide synthase activity, which could lead to lower exhaled nitric oxide levels.

The measurement of the fractional concentration of exhaled nitric oxide (FENO) is a non-invasive method to assess airway inflammation in adults and children with asthma. The hypotheses of the current study are that women using oral contraceptives will have lower FENO levels and better asthma control as assessed by the Asthma Control TestTM during different phases of the menstrual cycle. This study may identify clinically important changes in FENO levels and asthma control during the menstrual cycle and modification of these effects by oral contraceptive pills. This data may lead to future studies aimed at identifying therapeutic roles for hormones in asthma therapy in women.


Condition
Asthma
Regulatory T Cell Function

MedlinePlus related topics: Asthma
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Oral Contraceptives and Asthma Control

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Exhaled Nitric Oxide Levels [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma Control Test Scores [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Regulatory T Cell Activity [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
OCP Users
Non-users of OCPs

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from University of Kentucky clincis and the surrounding community.

Criteria

Inclusion Criteria:

  • Asthmatic
  • Female
  • Aged 18-45
  • User of combination oral contraceptive pills OR non-user of any hormonal contraception

Exclusion Criteria:

  • Smoker
  • Other underlying lung disease (i.e., emphysema, cystic fibrosis, lung cancer)
  • User of oral contraceptives that are not combination (estrogen + progesterone) pills
  • User of non-oral hormonal contraception
  • Have been treated in the prior 4 weeks with oral steroids
  • Have had a respiratory infection in the prior 4 weeks
  • Asthma under poor control at study entry
  • Presence of severe asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662051

Contacts
Contact: James Temprano, MD, MHA 859-323-5199 jtemp1@email.uky.edu
Contact: Tonya Gardner, CCRC 859-323-5199 tlgard2@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: James Temprano, M.D., M.H.A.     859-323-5199     jtemp1@email.uky.edu    
Principal Investigator: James Temprano, M.D., M.H.A.            
Sponsors and Collaborators
University of Kentucky
American College of Allergy, Asthma and Immunology
Investigators
Principal Investigator: James Temprano, MD, MHA University of Kentucky
  More Information

No publications provided

Responsible Party: University of Kentucky ( James Temprano, MD, MHA )
Study ID Numbers: 07-0589-F6A
Study First Received: April 15, 2008
Last Updated: February 20, 2009
ClinicalTrials.gov Identifier: NCT00662051     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Asthma
Exhaled Nitric Oxide
Asthma Control Test

Study placed in the following topic categories:
Nitric Oxide
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Contraceptive Agents
Lung Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Bronchial Diseases
Immune System Diseases
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Asthma
Reproductive Control Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009