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

21 juin 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Asthme

Type d'étude

Observationnel

Inscription (Anticipé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Eileen Wang, MD, MPH
Numéro de téléphone: 303-270-2796
E-mail: WANGE@NJHEALTH.ORG

Lieux d'étude

États-Unis
- Colorado
  - Denver, Colorado, États-Unis, 80206
    - Recrutement
    - National Jewish Health
    - Contact:
      
      Eileen Wang, MD, MPH

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change From Baseline in Asthma Control Test Délai: Baseline and Week 52	Standardized asthma symptom survey	Baseline and Week 52

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change From Baseline in Significant asthma exacerbations (SAEs) Délai: 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 Délai: 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) Délai: 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 Délai: 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 Délai: Baseline and Week 52	Doses taken/doses prescribed average out over study duration	Baseline and Week 52
Change From Baseline in Steps Per Day Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Jewish Health

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 février 2021

Achèvement primaire (Anticipé)

15 juillet 2022

Achèvement de l'étude (Anticipé)

15 juillet 2023

Dates d'inscription aux études

Première soumission

22 janvier 2021

Première soumission répondant aux critères de contrôle qualité