Asthma MedDRA version: 17.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
RSPR Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent must be obtained before any trial related procedures are performed 2) Age =18 and 20 ppb (calculated average of 2 independent FENO measurements) at Visit 1 5) Baseline FEV1 >80% of the predicted normal value at Visit 1 6) Demonstration of PD15 at =315 mg mannitol =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Lower respiratory tract infection 2 x 400 µg budesonide /day (dose must not be changed <4 weeks prior to Visit 1 and during the trial) • Oral corticosteroids • Any systemic immunomodulatory therapy • Any systemic anti-rheumatic therapy • Anti-IL-4 therapy - Clinically significant comorbidities that may be compromised by induced bronchospasm or repeated spirometry as judged by Investigator - Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, cardiac, haematological, gastrointestinal, endocrine, inflammatory, autoimmune, pulmonary, neurological, cerebral or psychiatric disease evaluated by the Investigator to interfere with effect of the trial drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of single doses of 40 mg and 400 mg CRD007 in subjects with asthma ;Secondary Objective: •To determine the protective effect of CRD007 on release of mast cell mediators by measuring urine excretion of biomarkers (9a,11ß-PGF2; LTE4; N-methylhistamine) before and after mannitol challenge •To investigate the safety profile of single doses of 40 mg and 400 mg CRD007 ;Primary end point(s): PD15 for mannitol after treatment with CRD007 and placebo;Timepoint(s) of evaluation of this end point: 3 hours after administration of IMP/Placebo a mannitol challenge test will be performed to evaluate the primary endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PD15 for mannitol after treatment with CRD007 in relation to pemirolast blood concentration a) Response Dose Ratio after treatment with CRD007 and placebo b) Response Dose Ratio induced by mannitol challenge after treatment with CRD007 in relation to pemirolast blood concentrations c) Change in urine excretion of biomarkers for mast cell mediators (9a,11ß-PGF2; LTE4; N-methylhistamine) in relation to CRD007 treatment d) Adverse events ;Timepoint(s) of evaluation of this end point: 3 hours after administration of IMP/Placebo a mannitol challenge test will be performed to evaluate the secondary endpoints (a,b) Less than 10 minutes before the mannitol challenge test and 30 and 60 minutes after the test (c) During the trial (visit 1-5) (d) | — |
Countries
Denmark
Contacts
Public ContactCarl-Johan Dalsgaard
RSPR Pharma AB
Outcome results
None listed