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Dupilumab for Asthma (ATLAS Trial)
ATLAS Trial Summary
This trial is testing whether dupilumab can prevent or slow the rate of decline in lung function in patients with uncontrolled moderate to severe asthma, compared to standard of care therapy. The trial will last for 3 years, with a follow-up period of up to 12 weeks after treatment.
ATLAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowATLAS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 188 Patients • NCT04033367ATLAS Trial Design
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Who is running the clinical trial?
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- I might have a parasite infection or have taken antiparasitic drugs recently.I am 18 years old or older.I have not received a live vaccine within the last 4 weeks.I have had one or more severe flare-ups in the past year.I am HIV positive.I have active TB, a non-tuberculous mycobacterial infection, or untreated TB history.My lung function improved significantly after using a quick-relief inhaler.I am at least 18 years old or the legal age of consent where the study is conducted.I am currently experiencing severe asthma attacks.I have used corticosteroids for more than 3 days or was hospitalized for asthma.My asthma control score is 1.5 or higher.My lung function test shows less than 80% of the normal airflow.I am not currently on antibiotics, antivirals, or antifungals for an infection.Your FeNO level is higher than 35 parts per billion before the randomization visit.I have been on a stable dose of medium to high inhaled corticosteroids and another controller for over a month.I've been on a strong asthma treatment with two controllers for over a month.I haven't taken any biologic therapy or immunosuppressants in the last 4 weeks or 5 half-lives, whichever is longer.I have a lung or systemic disease linked to high eosinophil counts, not asthma.I have had cancer or still have it within the last 5 years.I have a weak immune system or history of serious infections.Your asthma control questionnaire score is 1.5 or higher before the randomization.I have been diagnosed with asthma for at least a year.I have had a severe asthma attack treated with steroids in the last month.You are currently smoking, or you quit smoking less than 6 months ago.I have a chronic lung condition like COPD or severe asthma.I have smoked more than 10 pack-years.You have had a severe allergic reaction to dupilumab or any other similar medication.My lung function improved significantly after using a quick-relief inhaler.I have been diagnosed with asthma for at least a year.
- Group 1: Dupilumab
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Could you elaborate on any other investigations that have been conducted using Dupilumab?
"As of this moment, Dupilumab is the focus of 49 different clinical studies. Of these, 13 are in their final stage of development (Phase 3). Although most trials for this medication are based in Palo Alto, California there exists an impressive network of 2,602 locations running trials on its behalf."
What medical purposes does Dupilumab typically serve?
"Dupilumab can be an effective treatment option for those suffering from dermatitis, atopic conditions, and eosinophilic issues not responding to corticosteroid therapy."
Can individuals currently access the benefits of this trial?
"Affirmative. Clinicaltrials.gov indicates that this trial is in its active recruitment period, having been first posted on December 16th 2021 and most recently updated on October 6th 2022."
Has Dupilumab achieved the necessary FDA accreditation?
"There is ample evidence of dupilumab's safety, thus it has earned a rating of 3. This drug is already approved for use and this trial will help further our understanding with regards to its efficacy."
Is this an unprecedented research endeavor?
"Dupilumab has been evaluated in a plethora of trials, with 49 still ongoing across 436 cities and 43 countries. Initially funded by Sanofi, the first clinical trial was conducted back in 2015 and involved 880 patients, culminating in Phase 3 drug approval. Since then 18360 other studies have already concluded."
How many participants are being evaluated in this clinical research?
"To complete this clinical trial, 1828 suitable individuals are needed. Sanofi is taking responsibility for the study and it will be conducted at Novel Research LLC-Site Number:8400124 in Houston, Texas as well as Investigational Site Number :1240015 in Ajax, Ontario."
Are there various facilities conducting this research effort within the city limits?
"This clinical trial requires 100 patients to be recruited, with Novel Research LLC (Houston), Investigational Site Number 1240015 (Ajax) and Metroplex Pulmonary & Sleep Center-Site Number 840014 (McKinney) among the list of recruiting locations. The other 97 sites have yet to be revealed."
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?
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