Oral Contraceptives and Asthma Control

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
American College of Allergy, Asthma and Immunology
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00662051
First received: April 15, 2008
Last updated: August 7, 2013
Last verified: August 2013
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Contraceptives and Asthma Control

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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
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: NCT00662051

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
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
ClinicalTrials.gov Identifier: NCT00662051     History of Changes
Other Study ID Numbers: 07-0589-F6A
Study First Received: April 15, 2008
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014