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

21 juni 2021 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Astma

Studietyp

Observationell

Inskrivning (Förväntat)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Eileen Wang, MD, MPH
Telefonnummer: 303-270-2796
E-post: WANGE@NJHEALTH.ORG

Studieorter

Förenta staterna
- Colorado
  - Denver, Colorado, Förenta staterna, 80206
    - Rekrytering
    - National Jewish Health
    - Kontakt:
      
      Eileen Wang, MD, MPH

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Change From Baseline in Asthma Control Test Tidsram: Baseline and Week 52	Standardized asthma symptom survey	Baseline and Week 52

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Change From Baseline in Significant asthma exacerbations (SAEs) Tidsram: 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 Tidsram: 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) Tidsram: 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 Tidsram: 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 Tidsram: Baseline and Week 52	Doses taken/doses prescribed average out over study duration	Baseline and Week 52
Change From Baseline in Steps Per Day Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Jewish Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 februari 2021

Primärt slutförande (Förväntat)

15 juli 2022

Avslutad studie (Förväntat)

15 juli 2023

Studieregistreringsdatum

Först inskickad

22 januari 2021

Först inskickad som uppfyllde QC-kriterierna