EUCTR2015-002656-26-GB
Active, not recruiting
Phase 1
A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects with Asthma. - RSPR-008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- RSPR Pharma AB
- Enrollment
- 168
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent must be obtained before any trial related procedures are
- •2\. Age \=18 years old
- •3\. Diagnosis of asthma according to GINA Guidelines (1\)
- •4\. Atopic phenotype as assessed by Investigator based on:
- •o Positive skin prick test or
- •o Positive specific IgE test or
- •o Medical history
- •5\. Treated with ICS and LABA for at least 12 weeks prior to Visit 1 with a daily ICS dose equivalent to \=400µg and \=800µg budesonide and a daily stable LABA dose.
- •6\. Blood eosinophils \=0\.05\*109/L at Visit 1
- •7\. Demonstration of FEV1 \=60% of the predicted value at Visit 1
Exclusion Criteria
- •1\. Lower respiratory tract infection \<6 weeks prior to Visit 1
- •2\. Current smokers
- •3\. Ex\-smokers with a smoking history of \>10 pack years (e.g. 10 pack years \= 1 pack/day x
- •10 years, or ½ pack/day x 20 years). An ex\-smoker may be defined as a subject who has
- •not smoked for \>6 months prior to Visit 1
- •4\. Treatment with any of the medications listed below \<6 weeks prior to Visit 1:
- •o Systemic (oral or parental) corticosteroids
- •o Any systemic immunomodulatory therapy introduced \<6 months prior to Visit 1
- •o Any treatment with biologics
- •5\. BMI which is judged by the investigator to interfere with trial procedures and results
Outcomes
Primary Outcomes
Not specified
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