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Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mucociliary clearance (MCC) rate | MCC is measured using an aerosol-based nuclear imaging technique | Measured at 12 weeks after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1% predicted | Assessed using spirometry after bronchodilator administration. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Moore | Contact | 412-648-6726 | mooreja6@upmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Pittsburgh Asthma Institute at UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Dupilumab and placebo will be provided in identically matched 1.14 mL pre-filled syringes. To protect the blind, each treatment kit of 1.14 mL (dupilumab / placebo) glass pre-filled syringes will be prepared such that the treatments (dupilumab and its matching placebo) are identical and indistinguishable and will be labeled with a treatment kit number. The randomized treatment kit number list will be generated by Sanofi Regeneron
| Placebo | Other | 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). |
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| 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 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 from baseline to 12 weeks after start of treatment |
| Whole lung MCC90, AAC90 | Measured via mucociliary clearance imaging | Measured from baseline to 12 weeks after start of treatment |
| Peripheral and central lung MCC90, MCC240, AAC90 | Measured via mucociliary clearance imaging | Measured from baseline to 12 weeks after start of treatment |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000073893 |
| Sugars |