Oral Contraceptives and Asthma Control
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.
調査の概要
状態
研究の種類
連絡先と場所
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ、40536
- University of Kentucky
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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OCP Users
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Non-users of OCPs
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Exhaled Nitric Oxide Levels
時間枠:2 months
|
2 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Asthma Control Test Scores
時間枠:2 months
|
2 months
|
Regulatory T Cell Activity
時間枠:2 months
|
2 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:James Temprano, MD, MHA、University of Kentucky
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。