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Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study (MORRE)

21 de junho de 2021 atualizado por: National Jewish Health

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.

Visão geral do estudo

Status

Recrutamento

Condições

Asma

Tipo de estudo

Observacional

Inscrição (Antecipado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Eileen Wang, MD, MPH
Número de telefone: 303-270-2796
E-mail: WANGE@NJHEALTH.ORG

Locais de estudo

Estados Unidos
- Colorado
  - Denver, Colorado, Estados Unidos, 80206
    - Recrutamento
    - National Jewish Health
    - Contato:
      
      Eileen Wang, MD, MPH

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Participants 18-85 years of age with moderate-to-severe asthma at the time of enrollment and eligible for omalizumab therapy.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change From Baseline in Asthma Control Test Prazo: Baseline and Week 52	Standardized asthma symptom survey	Baseline and Week 52

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change From Baseline in Significant asthma exacerbations (SAEs) Prazo: 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
Change From Baseline in Lung Function Prazo: Baseline and Week 52	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	Baseline and Week 52
Global evaluation of treatment effectiveness (GETE) Prazo: Baseline and Week 52	Standard asthma survey that is scored to assess omalizumab responders	Baseline and Week 52
Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication Prazo: Baseline and Week 52	Number of inhalations per day averaged out over study duration Number of inhalations per night per month averaged out over study duration	Baseline and Week 52
Change From Baseline in Adherence of Inhaled Corticosteroids Prazo: Baseline and Week 52	Doses taken/doses prescribed average out over study duration	Baseline and Week 52
Change From Baseline in Steps Per Day Prazo: Baseline and Week 52	Steps per day average out over study duration	Baseline and Week 52
Change From Baseline in Duration of Exercise Per Day Prazo: Baseline and Week 52	Minutes exercise per day average out over study duration	Baseline and Week 52
Change From Baseline in Intensity of Exercise Per Day Prazo: Baseline and Week 52	Minutes exercise/day x average heart rate during the exercise	Baseline and Week 52
Change From Baseline in Duration of Interrupted Sleep per Night Prazo: Baseline and Week 52	Hours of uninterrupted sleep as recorded by Fitbit device	Baseline and Week 52
Change From Baseline in Number of Awakenings per Night Prazo: Baseline and Week 52	Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit	Baseline and Week 52
Change From Baseline in the Monthly Symptom Questionnaire Scores Prazo: Baseline and Week 52	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.	Baseline and Week 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Jewish Health

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de fevereiro de 2021

Conclusão Primária (Antecipado)

15 de julho de 2022

Conclusão do estudo (Antecipado)

15 de julho de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ