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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.

Must not have

Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e. oral subcutaneous, mechanical, or surgical contraception). Males who are sexually active must agree to use an acceptable method of birth control (i.e. barrier methods with vaginal spermicide) or have a female partner practicing an approved birth control method for females.

Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 - week 68

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant and will use birth control during the study.

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I need steroids or other immune system medications for my health condition.

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My cancer has been in remission for less than a year.

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I have not received a live vaccine in the last 4 weeks.

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I am currently undergoing immunotherapy treatment.

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I currently smoke or use vaping devices.

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I have a significant lung condition that is not asthma.

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I am on high-dose inhalers or daily steroids for my lung condition.

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I've had a severe asthma attack in the last 2 years that needed breathing support or caused a seizure.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of asthma exacerbations during the 12-month treatment period

Secondary study objectives

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

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

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

~11960

0 / 16Eligibility criteria met