AsthmaPhase 2PANDANCT05347771
Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents
A Phase 2 study testing Dupilumab in people with Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 May 2022to 15 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent
- Are male and female aged 6-17 years at Visit 0
- Participant has a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE01 Manual of Operations (MOP). Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion.
- Participant has a diagnosis of asthma made > 1 year prior to recruitment. Participants who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
- Participant has had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization).
- At Visit 0 (screening), participant must have the following requirement for asthma controller medication:
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- Participants aged 6 to 11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent.
- 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.
- Have peripheral blood eosinophils ≥150 cells/mcl and/or FeNO ≥ 20ppb obtained at Visit 0 or via another CAUSE protocol within 6 months.
- Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to randomization.
- Have documentation of current medical insurance with prescription coverage at Visit 0.
Who cannot join
- Parent or guardian is not able or willing to give written informed consent or comply with study protocol.
- Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study.
- Are currently receiving immunotherapy.
- Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to randomization.
- Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta agonist (LABA) one puff twice daily or its equivalent plus Long-acting muscarinic antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0.
- Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Participants 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 partner practicing an approved birth control method.
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- Have a known, pre-existing clinically important lung condition other than asthma.
- Have a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization.
- Is a current smoker or is currently using any electronic cigarette or vaping device (e.g. e-cigarette, e- cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods).
- Have a known immunodeficiency disease.
- Have a known, active pre-existing parasitic infection or are undergoing treatment for a parasitic infection. Once the participant has been successfully treated, the participant may be reevaluated.
- Use of investigational drugs within 4 weeks of randomization
- Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- Will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who is not willing to change their asthma medications to follow the Protocol CAUSE- 01 PANDA.
- Have a known history of allergic reaction to dupilumab.
- Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure.
- Have received a live (attenuated) vaccine within 4 weeks of Visit 0.
- Have an eosinophil count of ≥1500 cells/mcl at Visit 0.
- Potential participants may be reassessed as outlined in the Protocol CAUSE-01 MOP.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Hospital Colorado: Allergy Program
Aurora, Colorado, 80045
Boston Children's Hospital: Department of Immunology
Boston, Massachusetts, 02215
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, 45229
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
New York, New York, 10029
Columbia University Medical Center: Division of Pediatric Pulmonology
New York, New York, 10032
Washington University at St. Louis
St Louis, Missouri, 63110
Children's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) (CAUSE-01)
This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.
Read the detailed description
Protocol CAUSE-01 PANDA is a multicenter, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for the reduction of asthma exacerbations in urban children and adolescents 6 to 17 years with T2-high exacerbation-prone asthma. Approximately 240 participants will be randomized 2:1 to one of two study arms: 1) guidelines-based asthma treatment + dupilumab, or 2) guidelines-based asthma treatment + placebo. Study treatment will continue for 1 year with an additional 3 months of follow-up following completion of study treatment.
An initial Screening Visit will be followed by a 4-week run-in period. After the run-in, participants who continue to meet eligibility criteria will be randomized to one of the 2 treatment arms and receive their first injection. Over the next 2 weeks, participants will return to the clinic for 3 early treatment response visits. Participants will receive injections of dupilumab, or placebo administered subcutaneously every two weeks (Q2W), or every four weeks (Q4W), over 12 months. Each participant will have Evaluation and Management (E\&M) visits every 3 months where their asthma and rhinitis will be assessed and adjustments made to their medications based on asthma guidelines.
Participants will be asked to monitor and self-report cold symptoms throughout the treatment period. Participants will be asked to complete up to three paired cold visits. At the time of a cold, participants will be asked to come into the clinic for collection of blood and nasal secretions for associated mechanistic studies. Approximately three days after the clinic visit, participants will complete symptom assessments and will be asked to collect nasal samples at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent, IL4Ra mAb
Dupilumab is a recombinant DNA-derived humanized IgG4ĸ monoclonal antibody that selectively binds to anti IL-4R monoclonal antibody (mAb).
PlaceboDrug
Also called Placebo for Dupilumab
The composition of the placebo for dupilumab is the same as the active study drug without the dupilumab.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | 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:
Those weighing 15 kg to less than 30 kg will receive 300 mg every four weeks (Q4W). Participants in this weight category who were randomized before July 1, 2024, were assigned to a 100mg Q2W and will not be transitioned to the Q4W dosing schedule.
Those with a body weight of 30 kg or more will receive 200 mg Q2W. Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | 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 or Q4W based on their body weight and date of randomization.:
The injection volume of placebo will be matched to the corresponding dupilumab dose based on participant body weight. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of asthma exacerbations during the 12-month treatment period
Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following dosage: the course for prednisone, prednisolone, or methylprednisolone will be at least 20 mg daily dose for 3 of 5 consecutive days. The course for dexamethasone will be at least a 10 mg single daily dose. If a corticosteroid burst for the treatment of an asthma exacerbation is prescribed by a non-CAUSE clinician, it will be counted regardless of dose.
Measured: Week 4 (Treatment initiation) - Week 54 (Completion of treatment)
Secondary outcomes (8)
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) % Predicted
FEV1 is air volume exhaled in 1 second during spirometry. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.
This measurement will be performed by trained and certified clinical research staff according to American Thoracic Society standards as performed routinely in usual care as part of subspecialist management of asthma.
Measured: Week 4 to Week 68
Days with symptoms, nights with symptoms, and day and night albuterol use.
Number of days with asthma symptoms as defined by the participant report of daytime asthma symptoms over the preceding 14-day period.
Number of nights with asthma symptoms as defined by participant report of nighttime asthma symptoms over the preceding 14-day period.
Number of days with albuterol use as defined by participant report of days of albuterol (bronchodilator) use over the preceding 14-day period.
Number of nights albuterol use as defined by participant report of nights of albuterol (bronchodilator) use over the preceding 14-day period.
Measured: Week 4 to Week 68
Asthma control measured by the Asthma Control Questionnaire-5
The Asthma Control Questionnaire-5 is a validated tool that will be used to assess overall asthma control over the last 4 weeks. The Range is 0-6, with higher scores indicating worse asthma control.
Measured: Week 4 to Week 60
Time to first asthma exacerbation
Time between initiation of treatment and first asthma exacerbation or the end of participant follow-up visits.
Measured: Week 4 to Week 68
Quality of life as measured by the PROMIS Asthma Impact Short Forms (Pediatric or Parent Proxy).
As measured by the pediatric patient-reported (ages 8-17) or proxy-reported (ages 6-7) PROMIS Asthma Impact Short Forms.
Measured: Week 4 to Week 68
Asthma burden as measured by Combined Asthma Severity Index (CASI)
The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment. The CASI score ranges from 0 to 20 points, with higher scores indicating higher levels of severity, and includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations.
Measured: Week 4 to Week 68
Rhinitis symptoms as measured by Modified Rhinitis Symptoms Utility Index (MRSUI)
The Modified Rhinitis Symptom Utility Index (MRSUI) assesses the frequency and severity (degree of bothering: not bothered, somewhat bothered, bothered a lot) of the participant's (1) stuffy or blocked nose, (2) runny nose, (3) sneezing, (4) itchy, watery eyes, and (5) itchy nose or throat over the preceding 14-day period.
Measured: Week 4 - Week 68
Related adverse events and serious adverse events in the course of treatment
The number of adverse events (AEs) by severity and relationship to study drug will be used to assess safety.
The number of serious adverse events (SAEs) by severity and relationship to study drug will be used to assess safety.
Measured: Week 4 to Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start4 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Childhood Asthma in Urban Settings (CAUSE), Regeneron Pharmaceuticals, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel J. Jackson, M.D., Study chair, University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347771
- Sponsor's protocol ID
- DAIT CAUSE-01
- Acronym
- PANDA
- Status last verified
- Jan 2026
- First submitted
- 20 Apr 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share data upon study completion in Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) (CAUSE-01)
- ClinicalTrials.gov ID
- NCT05347771
- Acronym / sponsor ID
- PANDA / DAIT CAUSE-01
- Conditions
- Asthma
- Keywords
- asthma, CAUSE, PANDA, T2, dupilumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Childhood Asthma in Urban Settings (CAUSE), Regeneron Pharmaceuticals, Rho Federal Systems Division, Inc.
- Study start
- 4 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.
Detailed description
Protocol CAUSE-01 PANDA is a multicenter, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for the reduction of asthma exacerbations in urban children and adolescents 6 to 17 years with T2-high exacerbation-prone asthma. Approximately 240 participants will be randomized 2:1 to one of two study arms: 1) guidelines-based asthma treatment + dupilumab, or 2) guidelines-based asthma treatment + placebo. Study treatment will continue for 1 year with an additional 3 months of follow-up following completion of study treatment.
An initial Screening Visit will be followed by a 4-week run-in period. After the run-in, participants who continue to meet eligibility criteria will be randomized to one of the 2 treatment arms and receive their first injection. Over the next 2 weeks, participants will return to the clinic for 3 early treatment response visits. Participants will receive injections of dupilumab, or placebo administered subcutaneously every two weeks (Q2W), or every four weeks (Q4W), over 12 months. Each participant will have Evaluation and Management (E\&M) visits every 3 months where their asthma and rhinitis will be assessed and adjustments made to their medications based on asthma guidelines.
Participants will be asked to monitor and self-report cold symptoms throughout the treatment period. Participants will be asked to complete up to three paired cold visits. At the time of a cold, participants will be asked to come into the clinic for collection of blood and nasal secretions for associated mechanistic studies. Approximately three days after the clinic visit, participants will complete symptom assessments and will be asked to collect nasal samples at home
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabParticipants 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: Those weighing 15 kg to less than 30 kg will receive 300 mg every four weeks (Q4W). Participants in this weight category who were randomized before July 1, 2024, were assigned to a 100mg Q2W and will not be transitioned to the Q4W dosing schedule. Those with a body weight of 30 kg or more will receive 200 mg Q2W. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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 or Q4W based on their body weight and date of randomization.: The injection volume of placebo will be matched to the corresponding dupilumab dose based on participant body weight. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent
- Are male and female aged 6-17 years at Visit 0
- Participant has a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE01 Manual of Operations (MOP). Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion.
- Participant has a diagnosis of asthma made > 1 year prior to recruitment. Participants who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
- Participant has had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization).
Key exclusion criteria (19 listed)
- Parent or guardian is not able or willing to give written informed consent or comply with study protocol.
- Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study.
- Are currently receiving immunotherapy.
- Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to randomization.
- Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta agonist (LABA) one puff twice daily or its equivalent plus Long-acting muscarinic antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: Dupixent, IL4Ra mAbDupilumab is a recombinant DNA-derived humanized IgG4ĸ monoclonal antibody that selectively binds to anti IL-4R monoclonal antibody (mAb). | Drug | Dupilumab |
| PlaceboAlso: Placebo for DupilumabThe composition of the placebo for dupilumab is the same as the active study drug without the dupilumab. | Drug | Placebo |
Primary outcome
Number of asthma exacerbations during the 12-month treatment period
Time frame: Week 4 (Treatment initiation) - Week 54 (Completion of treatment)
Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following dosage: the course for prednisone, prednisolone, or methylprednisolone will be at least 20 mg daily dose for 3 of 5 consecutive days. The course for dexamethasone will be at least a 10 mg single daily dose. If a corticosteroid burst for the treatment of an asthma exacerbation is prescribed by a non-CAUSE clinician, it will be counted regardless of dose.
8 secondary outcomes
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) % Predicted
Time frame: Week 4 to Week 68
Days with symptoms, nights with symptoms, and day and night albuterol use.
Time frame: Week 4 to Week 68
Asthma control measured by the Asthma Control Questionnaire-5
Time frame: Week 4 to Week 60
Time to first asthma exacerbation
Time frame: Week 4 to Week 68
Quality of life as measured by the PROMIS Asthma Impact Short Forms (Pediatric or Parent Proxy).
Time frame: Week 4 to Week 68
Asthma burden as measured by Combined Asthma Severity Index (CASI)
Time frame: Week 4 to Week 68
Rhinitis symptoms as measured by Modified Rhinitis Symptoms Utility Index (MRSUI)
Time frame: Week 4 - Week 68
Related adverse events and serious adverse events in the course of treatment
Time frame: Week 4 to Week 68
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Share data upon study completion in Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J. Jackson, M.D. study chair
University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of asthma exacerbations during the 12-month treatment period (time frame: Week 4 (Treatment initiation) - Week 54 (Completion of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.