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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Eileen Wang, MD, MPH
- 전화번호: 303-270-2796
- 이메일: WANGE@NJHEALTH.ORG
연구 장소
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Colorado
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Denver, Colorado, 미국, 80206
- 모병
- National Jewish Health
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연락하다:
- Eileen Wang, MD, MPH
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Asthma Control Test
기간: Baseline and Week 52
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Standardized asthma symptom survey
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Baseline and Week 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Significant asthma exacerbations (SAEs)
기간: Baseline and Week 52
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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.
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Baseline and Week 52
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Change From Baseline in Lung Function
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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