Oral Contraceptives and Asthma Control

Asthma Clinical Trial

Official title:

Oral Contraceptives and Asthma Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00662051
• Other study ID #: 07-0589-F6A
• Status: Withdrawn
• Phase: N/A
• First received: April 15, 2008
• Last updated: August 7, 2013
• Start date: April 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2013
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Regulatory T Cell Function

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	American College of Allergy, Asthma and Immunology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled Nitric Oxide Levels		2 months	No
Secondary	Asthma Control Test Scores		2 months	No
Secondary	Regulatory T Cell Activity		2 months	No