Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study (MORRE)
Develop new real-world evidence indicators of worsening and improving asthma. Scientists will measure (1) steps per day, (2) duration and intensity of exercise per day, (3) sleep duration and the number of awakenings per night using Fitbit activity trackers. Scientists will measure asthma symptoms using a once-monthly custom survey delivered to participant smartphones via Twilio. Scientists may measure rescue medication use and adherence to maintenance medications using digital inhaler devices. Scientists will correlate the above measures to participant-reported significant asthma exacerbations (SAEs), lung function (FEV1), and standardized surveys (i.e. the asthma control test (ACT) and global evaluation of treatment effectiveness (GETE)(4)) collected in clinic every 3 months. Coordinators will record any medication changes or reported medication side effects.
Determine response to omalizumab therapy. After participants are placed on omalizumab therapy as part of standard medical care, scientists will determine whether and how real-world evidence can be used to gauge responses to omalizumab. Then, scientists will determine which features, or combination of features, are the best indicators of disease control in the real world.
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Eileen Wang, MD, MPH
- 電話番号：303-270-2796
- メール：WANGE@NJHEALTH.ORG
研究場所
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Colorado
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Denver、Colorado、アメリカ、80206
- 募集
- National Jewish Health
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コンタクト：
- Eileen Wang, MD, MPH
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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:
- A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months OR an asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent) for at least 1 month prior to enrollment.
- Participants will need access to a smartphone.
Exclusion Criteria:
- Active smoking and any significant comorbid conditions that could inadvertently interfere with study results as determined by the study investigators (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
- Conditions that require bursts of oral corticosteroids
- Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others)
- Other disease that may mimic asthma, including vocal cord dysfunction, hypersensitivity pneumonitis, or tracheobronchomalacia.
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
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Asthma Control Test
時間枠：Baseline and Week 52
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Standardized asthma symptom survey
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Baseline and Week 52
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Significant asthma exacerbations (SAEs)
時間枠：Baseline and Week 52
|
A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for participants receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid).
The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 observation or 52-week treatment period in each treatment group.
|
Baseline and Week 52
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Change From Baseline in Lung Function
時間枠：Baseline and Week 52
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FEV1 % predicted pre- and post-bronchodilator FEV1 absolute (L) pre- and post-bronchodilator FVC % predicted pre- and post-bronchodilator FVC absolute (L) pre- and post-bronchodilator Bronchodilator response: % change in FEV1 after bronchodilator FEV1/FVC ratio: absolute and % predicted Aggregated measure: significant vs non significant bronchodilator reversibility.
Significant reversibility defined as greater than or equal to 12% and 200mL increase in FEV1 or FVC
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Baseline and Week 52
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Global evaluation of treatment effectiveness (GETE)
時間枠：Baseline and Week 52
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Standard asthma survey that is scored to assess omalizumab responders
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Baseline and Week 52
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Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication
時間枠：Baseline and Week 52
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Number of inhalations per day averaged out over study duration Number of inhalations per night per month averaged out over study duration
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Baseline and Week 52
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Change From Baseline in Adherence of Inhaled Corticosteroids
時間枠：Baseline and Week 52
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Doses taken/doses prescribed average out over study duration
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Baseline and Week 52
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Change From Baseline in Steps Per Day
時間枠：Baseline and Week 52
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Steps per day average out over study duration
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Baseline and Week 52
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Change From Baseline in Duration of Exercise Per Day
時間枠：Baseline and Week 52
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Minutes exercise per day average out over study duration
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Baseline and Week 52
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Change From Baseline in Intensity of Exercise Per Day
時間枠：Baseline and Week 52
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Minutes exercise/day x average heart rate during the exercise
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Baseline and Week 52
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Change From Baseline in Duration of Interrupted Sleep per Night
時間枠：Baseline and Week 52
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Hours of uninterrupted sleep as recorded by Fitbit device
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Baseline and Week 52
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Change From Baseline in Number of Awakenings per Night
時間枠：Baseline and Week 52
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Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit
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Baseline and Week 52
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Change From Baseline in the Monthly Symptom Questionnaire Scores
時間枠：Baseline and Week 52
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Each answer will be scored 1-10 points, depending on the answer, and added to create a survey score.
Higher scores indicate poorer asthma control.
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Baseline and Week 52
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。