Early Phase 1
N=9
In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02740049 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Concentration (pg/ml) of CXCL8 Cytokine in Cell Supernatant After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells. — 2090.0; 1835.2; 1863.7; 1815.1 pg/ml — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- VR588 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration (pg/ml) of CXCL8 Cytokine in Cell Supernatant After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells. |
2090.0; 1835.2; 1863.7; 1815.1; 1635.1; 7000.5 | 0.0002 sig |
| PRIMARY Percentage of Viable Cells Compared to Baseline After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells. |
100.0; 98.4; 95.4; 98.4; 102.9; 87.1 | 0.3994 |
| PRIMARY Relative Fluorescence Units of STAT1 Protein Phosphorylation After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells. |
0.80; 0.82; 0.74; 0.64; 0.60; 6.94 | 0.0104 sig |
Summary
Asthma is a long term disease of the lungs. In asthma patients the sensitive airway tubes narrow in reaction to something that irritates the airways such as allergens or environmental pollutants. There is currently no cure for asthma and new medicines or combinations of medicines are needed that will be of benefit to patients particularly those with a more severe disease.
Activation of certain signal molecules inside the lung cells may participate in the development of asthma and the response to allergens. Blocking these signal molecules specifically with medicines might therefore be beneficial in the treatment of asthma. In this study we want to test a new medicine that specifically targets a subset of signal molecules that are associated with the allergen response in the lung. In particular, we want to test this medicine on cells obtained from the lungs of asthma patients. Understanding the effects of this new medicine on these asthmatic lung cells will give vital information on how this new medicine works before we can test it in asthma patients.
Eligibility Criteria
Inclusion Criteria
All patients must be able to give informed consent.
The definition of severe asthma will be on the basis of:
- Treatment: High dose of ICS ± OCS ≥ 1000mcg FP daily or equivalent plus one other controller medication.
- Disease Control: Uncontrolled (GINA guidelines), three or more of the following present in any week in the preceding 4 weeks:
- Daytime symptoms more than twice per week
- Any limitation of activities
- Nocturnal symptoms once or more per week
- Need for reliever treatment more than twice per week
- Prebronchodilator FEV1 8% OR Decrease in FEV1 ≥ 12% and >200ml within 4 weeks after tapering treatment with one or more of the following drugs: ICS, OCS, LABA, SABA PLUS A history of wheeze occurring spontaneously or on exertion.
Exclusion Criteria
- Patients with a FEV1 < 1L
- Any other active lung condition
- Subjects unable to give consent
Data sourced from ClinicalTrials.gov (NCT02740049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.