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

21 juni 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Astma

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Eileen Wang, MD, MPH
Telefoonnummer: 303-270-2796
E-mail: WANGE@NJHEALTH.ORG

Studie Locaties

Verenigde Staten
- Colorado
  - Denver, Colorado, Verenigde Staten, 80206
    - Werving
    - National Jewish Health
    - Contact:
      
      Eileen Wang, MD, MPH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change From Baseline in Asthma Control Test Tijdsspanne: Baseline and Week 52	Standardized asthma symptom survey	Baseline and Week 52

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change From Baseline in Significant asthma exacerbations (SAEs) Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: Baseline and Week 52	Doses taken/doses prescribed average out over study duration	Baseline and Week 52
Change From Baseline in Steps Per Day Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Jewish Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 februari 2021

Primaire voltooiing (Verwacht)

15 juli 2022

Studie voltooiing (Verwacht)

15 juli 2023

Studieregistratiedata

Eerst ingediend

22 januari 2021

Eerst ingediend dat voldeed aan de QC-criteria