AsthmaPhase 4NCT04743791
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
A Phase 4 study testing Dupilumab in people with Asthma, run by Sally E. Wenzel MD at 1 site in United States.
Trial summary
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to Jun 2028
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
- Age > 18
- Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
- Reversibility >/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
- FEV1/Forced Vital Capacity (FVC)<75%
- Blood Eosinophils (EOS) >300 cells per mm3
- Exhaled Nitric Oxide (FeNO) >25 parts per billion (ppb)
- Asthma Control Test (ACT) score <20
Who cannot join
- Pregnant, nursing, or unwilling to test for pregnancy
- Current smoker or >10 pack year smoking history
- Body Mass Index (BMI)>37
- Respiratory infection in the last 30 days
- Use of antibiotics or oral prednisone in the last 30 days
- Current or previous use of dupilumab
Show all 12Show fewer
- Current or recent use of anti-IL-5 therapies
- Any other criteria that place the subject at unnecessary risk
- Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)
- History of non-skin cell cancer in the last 5 years
- Drug or alcohol addiction in the last 5 years
- Any other uncontrolled disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Pittsburgh Asthma Institute at UPMC
Pittsburgh, Pennsylvania, 15213
Sally Wenzel, MD, 412-647-9955, swenzel@pitt.edu
John Moore, 412-648-6726, mooreja6@upmc.edu
About this study
Official title: A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL.
PlaceboOther
Also called Sucrose
Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Active comparator | Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose. Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mucociliary clearance (MCC) rate
MCC is measured using an aerosol-based nuclear imaging technique
Measured: Measured at 12 weeks after the start of treatment
Secondary outcomes (6)
Change in FEV1% predicted
Assessed using spirometry after bronchodilator administration.
Measured: Measured from baseline to 12 weeks after start of treatment
Change in ACT score
Measured via the Asthma Control Test questionnaire. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma).
Measured: Measured from baseline to 12 weeks after start of treatment
Change in sputum eosinophils and T2 gene mean
Measured via sputum induction to obtain airway cells and fluid from patients.
Measured: Measured from baseline to 12 weeks after start of treatment
Change in mucus plugging score by CT
Radiologists will visually assess the presence or absence of mucus plugging in segmental airways and will provide a mucus plugging score
Measured: Measured from baseline to 12 weeks after start of treatment
Whole lung MCC90, AAC90
Measured via mucociliary clearance imaging
Measured: Measured from baseline to 12 weeks after start of treatment
Peripheral and central lung MCC90, MCC240, AAC90
Measured via mucociliary clearance imaging
Measured: Measured from baseline to 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start17 Oct 2022
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sally E. Wenzel MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally E. Wenzel MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743791
- Sponsor's protocol ID
- STUDY20020131
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT04743791
- Acronym / sponsor ID
- STUDY20020131
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sally E. Wenzel MDUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Feb 2021 (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.
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Active comparator | Drug: DupilumabTwo injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose. |
| Placebo | Placebo comparator | Other: PlaceboTwo injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
- Age > 18
- Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
- Reversibility >/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
- FEV1/Forced Vital Capacity (FVC)<75%
Key exclusion criteria (12 listed)
- Pregnant, nursing, or unwilling to test for pregnancy
- Current smoker or >10 pack year smoking history
- Body Mass Index (BMI)>37
- Respiratory infection in the last 30 days
- Use of antibiotics or oral prednisone in the last 30 days
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 |
|---|---|---|
| DupilumabDupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL. | Drug | Dupilumab |
| PlaceboAlso: SucroseSterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL). | Other | Placebo |
Primary outcome
Change in mucociliary clearance (MCC) rate
Time frame: Measured at 12 weeks after the start of treatment
MCC is measured using an aerosol-based nuclear imaging technique
6 secondary outcomes
Change in FEV1% predicted
Time frame: Measured from baseline to 12 weeks after start of treatment
Change in ACT score
Time frame: Measured from baseline to 12 weeks after start of treatment
Change in sputum eosinophils and T2 gene mean
Time frame: Measured from baseline to 12 weeks after start of treatment
Change in mucus plugging score by CT
Time frame: Measured from baseline to 12 weeks after start of treatment
Whole lung MCC90, AAC90
Time frame: Measured from baseline to 12 weeks after start of treatment
Peripheral and central lung MCC90, MCC240, AAC90
Time frame: Measured from baseline to 12 weeks after start of treatment
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 6 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Asthma, run by Sally E. Wenzel MD at 1 site 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact John Moore (412-648-6726, mooreja6@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mucociliary clearance (MCC) rate (time frame: Measured at 12 weeks after the start 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 6 Aug 2026.