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Dupilumab for COPD (NOTUS Trial)
NOTUS Trial Summary
This trial is testing the efficacy of a new drug, dupilumab, for treating moderate or severe COPD. The primary objective is to measure the annualized rate of acute COPD exacerbation (AECOPD) and the secondary objectives are to assess the effects of the drug on lung function and health-related quality of life. The trial will also evaluate the safety and tolerability of the drug and the incidence of antidrug antibodies (ADA).
NOTUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNOTUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NOTUS Trial Design
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- You have smoked the equivalent of at least 10 packs of cigarettes per year for 1 year.I have had a cough with mucus most days for 3 months.I have been on a stable dose of lung medication for at least 1 month.I have had, or will have, surgery to remove all or part of a lung and am not currently in the early stages of lung rehab.I do not have serious lung conditions other than COPD.I've had 2 or more lung flare-ups or 1 severe one in the last year while on my lung medication.You have high levels of a certain type of white blood cell called eosinophils in your blood.I have had a cough with mucus most days for 3 months without another known cause.I've had 2 or more lung flare-ups or 1 severe one in the last year while on my lung medication.I have been diagnosed with α-1 anti-trypsin deficiency.I have been on triple therapy for my lung condition for 3 months, or double therapy if I can't take ICS.I experience shortness of breath when moving.I need more than 4 liters per minute of oxygen, or over 2 liters to keep my oxygen level above 88%.I have not had a lung infection in the last 4 weeks.I have heart issues related to lung problems.I have moderate-to-severe COPD based on my lung function tests.I experience shortness of breath when moving around.I have asthma or a history of it, as per GINA guidelines.I have had a severe COPD flare-up within the last 4 weeks.Your blood test shows that you have a high level of a type of white blood cell called eosinophils.I have smoked at least 10 pack-years.I was diagnosed with COPD less than a year ago.I need a BiPAP machine due to high CO2 levels in my blood.I have been diagnosed with COPD by a doctor.I have moderate-to-severe COPD based on my lung function tests.
- Group 1: Placebo
- Group 2: Dupilumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are elderly patients eligible for this particular test?
"This trial's age limit starts at 40 and goes up to 85, as stated in the inclusion criteria."
Are there other examples of clinical trials using SAR231893?
"Dupilumab SAR231893 is being studied in 52 different clinical trials, with 14 of those studies currently in Phase 3. The Dupilumab SAR231893 trials are being conducted at 2662 locations around the world, a few of which are based in Louisville, Kentucky."
Has this research been conducted before?
"As of now, 52 clinical trials for Dupilumab SAR231893 are ongoing in 455 cities and 43 different countries. The first trial was conducted in 2015 and, sponsored by Sanofi, involved 880 individuals who completed Phase 3 drug approval. In the 6 years since then, 18320 studies have concluded."
Is this research program currently accepting new volunteers?
"Yes, the trial is currently ongoing and actively recruiting patients. The clinical study was first posted June 12th, 2020 with the latest update on October 14th, 2022. They are looking for 924 total patients from 100 different locations."
What are the approved medical applications for Dupilumab SAR231893?
"Dupilumab SAR231893 can help patients with atopic dermatitis, corticosteroid-resistant conditions, eosinophilia, and asthma."
Where are the patients being seen for this test?
"There are 100 available clinical trial sites, including Investigational Site Number :1240015 in Calgary, Investigational Site Number :8400015 in San Diego, and Investigational Site Number :8400111 in Bradenton."
What have been the most commonly reported side effects of Dupilumab SAR231893?
"There is existing clinical evidence to support Dupilumab SAR231893's safety, so it was given a score of 3."
How many people are the researchers testing this on in total?
"The sponsor, Regeneron Pharmaceuticals, will be conducting the study at two locations: Investigational Site Number :1240015 in Calgary, Alberta and Investigational Site Number :8400015 in San Diego, California. In order to begin testing, 924 individuals that fit the bill must be recruited."
Am I eligible to participate in this research?
"This clinical trial is enrolling 924 patients, within the ages of 40 and 85 who currently have airflow obstruction, chronic. It is required that patients also meet the following criteria: Current or former smokers with a smoking history of ≥10 pack-years., Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%)., Medical Research Council (MRC) Dyspnea Scale grade ≥2., Patient-reported history of signs"
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Investigational Site Number :1240014: < 48 hours
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