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

Asthma Clinical Trial

— MORRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724278
• Other study ID #: HS-3475
• Status: Recruiting
• Start date: February 5, 2021
• Est. completion date: July 15, 2023

Study information

• Verified date: June 2021
• Source: National Jewish Health
• Contact: Eileen Wang, MD, MPH
• Phone: 303-270-2796
• Email: wange[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Asthma Control Test	Standardized asthma symptom survey	Baseline and Week 52
Secondary	Change From Baseline in Significant asthma exacerbations (SAEs)	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
Secondary	Change From Baseline in Lung Function	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
Secondary	Global evaluation of treatment effectiveness (GETE)	Standard asthma survey that is scored to assess omalizumab responders	Baseline and Week 52
Secondary	Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication	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
Secondary	Change From Baseline in Adherence of Inhaled Corticosteroids	Doses taken/doses prescribed average out over study duration	Baseline and Week 52
Secondary	Change From Baseline in Steps Per Day	Steps per day average out over study duration	Baseline and Week 52
Secondary	Change From Baseline in Duration of Exercise Per Day	Minutes exercise per day average out over study duration	Baseline and Week 52
Secondary	Change From Baseline in Intensity of Exercise Per Day	Minutes exercise/day x average heart rate during the exercise	Baseline and Week 52
Secondary	Change From Baseline in Duration of Interrupted Sleep per Night	Hours of uninterrupted sleep as recorded by Fitbit device	Baseline and Week 52
Secondary	Change From Baseline in Number of Awakenings per Night	Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit	Baseline and Week 52
Secondary	Change From Baseline in the Monthly Symptom Questionnaire Scores	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