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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001483-29 | EudraCT Number |
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The study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo DPI | Placebo Comparator | Placebo by inhalation for 9 days |
|
| CHF6001 DPI Dose 2 | Experimental | CHF6001 by inhalation for 9 days |
|
| CHF6001 DPI Dose1 | Experimental | CHF6001 by inhalation for 9 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF6001 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Allergen challenge | after 9 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Induced Sputum | After 9 days of treatment | |
| Methacholine challenge | After 9 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of CHF6001 and its metabolites | The following parameters will be evaluated at the steady state: AUC0-t, AUC0-24h, Cmax, Cmin, Cav, tmax, tmin, t½, CL/F and Vz/F | after 9 days of treatment |
| Vital signs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | Medicines Evaluation Unit | Principal Investigator |
| Brian Leaker, MD | Respiratory Clinical Trials | Principal Investigator |
| Elizabeth Tranter, MD | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom | ||||
| Respiratory Clinical Trials |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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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 |
|---|---|
| C000596339 | tanimilast |
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|
| After single dose and 9 days of treatment |
| ECG | After single dose and 9 days of treatment |
| London |
| United Kingdom |
| Medicines Evaluation Unit | Manchester | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |