Oral Contraceptives and Asthma Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662051
Recruitment Status : Withdrawn
First Posted : April 21, 2008
Last Update Posted : August 9, 2013
American College of Allergy, Asthma and Immunology
Information provided by (Responsible Party):
University of Kentucky

Brief Summary:

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 or disease
Asthma Regulatory T Cell Function

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Contraceptives and Asthma Control
Study Start Date : April 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

OCP Users
Non-users of OCPs

Primary Outcome Measures :
  1. Exhaled Nitric Oxide Levels [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Asthma Control Test Scores [ Time Frame: 2 months ]
  2. Regulatory T Cell Activity [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662051

United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
American College of Allergy, Asthma and Immunology
Principal Investigator: James Temprano, MD, MHA University of Kentucky

Responsible Party: University of Kentucky Identifier: NCT00662051     History of Changes
Other Study ID Numbers: 07-0589-F6A
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

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

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