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Dupilumab for Preventing Asthma Attacks in Children (PANDA Trial)

Phase 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants aged 12 years and older, treatment with at least fluticasone 250 mcg plus long-acting beta agonist (LABA) DPI one puff twice daily or its equivalent.

Participants aged 6 to 11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 - week 68

Awards & highlights

PANDA Trial Summary

This trial is testing a new asthma medication to see if it can prevent exacerbations in children and adolescents with T2-high exacerbation-prone asthma.

Who is the study for?

This trial is for urban children and adolescents aged 6-17 with T2-high exacerbation-prone asthma. They must have had at least two asthma attacks in the past year, be on certain asthma medications, and not live in specific areas or have public health insurance. Participants need a diagnosis of asthma made over a year ago, meet certain blood test criteria, and can perform spirometry tests.Check my eligibility

What is being tested?

The study is testing Dupilumab as an additional treatment to prevent asthma flare-ups compared to a placebo (a substance with no therapeutic effect). It's conducted across multiple centers where participants are randomly assigned to either receive Dupilumab or placebo without knowing which one they're getting.See study design

What are the potential side effects?

Dupilumab may cause side effects such as injection site reactions, eye problems like redness or itching, joint pain, and allergic reactions. Some people might also experience cold sores or oral herpes.

PANDA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 12 or older and use a specific asthma inhaler or its equivalent.

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I am aged 6-11 and use a strong asthma inhaler or similar treatment.

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I am currently using medication to control my asthma.

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I've needed steroids or hospital care for asthma twice last year.

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I am between 6 and 17 years old.

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I have medical insurance that covers prescriptions.

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I can do the lung function test as per ATS standards.

PANDA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 - week 68

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 - week 68

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 - week 68 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of asthma exacerbations during the 12-month treatment period

Secondary outcome measures

Asthma burden as measured by Combined Asthma Severity Index (CASI)

Asthma control measured by the Asthma Control Questionnaire-5

Days with symptoms, nights with symptoms, and day and night albuterol use.

+5 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

OLE Period: Placebo/Dupilumab

DB Period: Dupilumab

OLE Period: Dupilumab/Dupilumab

PANDA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 Intervention

Participants between 12-17 years of age, will receive an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W). Participants between 6-11 years of age will not complete a loading dose and will receive injections based on their body weight: Participants with a body weight of 15 kg to less than 30 kg, will receive 100mg Q2W. Participants with a body weight of 30 kg or more, will receive 200 mg Q2W.

Group II: PlaceboPlacebo Group1 Intervention

Participants between 12-17 years of age, will receive an initial dose of placebo (two injections) followed by a placebo injection given every other week (Q2W). Participants between 6-11 years of age will not receive an initial loading dose of placebo and will receive injections Q2W based on their body weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~12230

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor

620 Previous Clinical Trials

380,145 Total Patients Enrolled

28 Trials studying Asthma

11,747 Patients Enrolled for Asthma

Rho Federal Systems Division, Inc.Industry Sponsor

41 Previous Clinical Trials

13,381 Total Patients Enrolled

4 Trials studying Asthma

1,097 Patients Enrolled for Asthma

Childhood Asthma in Urban Settings (CAUSE)UNKNOWN

Media Library

Dupilumab Clinical Trial Eligibility Overview. Trial Name: NCT05347771 — Phase 2

Asthma Research Study Groups: Dupilumab, Placebo

Asthma Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05347771 — Phase 2

Dupilumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05347771 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the screening requirements for this experiment?

"Children and teens with asthma who meet the age criteria of 6 to 17 years old may be eligible for this clinical trial, in which a total of 240 patients will be enrolled."

Answered by AI

In how many different places is this research being conducted?

"This trial has many locations still recruiting patients, such as Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology in Chicago, Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute in New york, and Children's Hospital Colorado: Allergy Program in Aurora."

Answered by AI

Are there any more places open for people who want to participate in this trial?

"The study is still recruiting patients, as of the most recent update on clinicaltrials.gov (6/1/2022). This trial was originally posted on 5/4/2022."

Answered by AI

Did the FDA sign-off on Dupilumab?

"Since Dupilumab is still in Phase 2 clinical trials, there is not yet conclusive evidence surrounding its efficacy. However, the data collected thus far indicates that it may be safe for use, and so it received a score of 2."

Answered by AI

Is the age limit for this trial set at 70 years or younger?

"As this study's eligibility criteria state, children aged 6-17 are able to enroll."

Answered by AI

How many individuals are being given this opportunity to participate in the trial?

"Yes, the information on clinicaltrials.gov says that this study is actively seeking candidates. The trial was first posted on May 4th, 2022 and was last edited on June 1st, 2022. The clinical trial is searching for 240 patients between 7 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

2022. "Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05347771.

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