Oral Contraceptives and Asthma Control

NCT00662051 | Withdrawn

• 1 other identifier: 07-0589-F6A
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Regulatory T Cell Function

Keywords

Asthma; Exhaled Nitric Oxide; Asthma Control Test

Outcome Measures

Primary Outcomes (1)

• Exhaled Nitric Oxide Levels

  2 months

Secondary Outcomes (2)

• Asthma Control Test Scores

  2 months

• Regulatory T Cell Activity

  2 months

Study Arms (2)

OCP Users

Non-users of OCPs

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• American College of Allergy, Asthma and Immunology: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• James Temprano, MD, MHA

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

US (1)