EUCTR2015-002656-26-DK
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
- Asthma
- Sponsor
- RSPR Pharma AB
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 8 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 performed
- •2\. Age \=18 years old
- •3\. Diagnosis of asthma according to GINA Guidelines (1\)
- •4\. Atopic phenotype
- •5\. Treated with ICS and LABA for at least 12 weeks prior to Visit 1
- •6\. Blood eosinophils \=0\.05\*109/L at Visit 1
- •7\. Demonstration of FEV1 at Visit 1 \= 60% of the predicted value
- •8\. Demonstration of ACQ6 \= 0\.5 and \=2\.5 at Visit 1
- •9\. Reversibility demonstrated at Visit 1 or 2
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. Lower respiratory tract infection \<6 weeks prior to Visit 1
- •2\. Smokers
- •3\. Treatment with disallowed medication
- •4\. Pregnant and breast\-feeding female subjects
- •5\. Receipt of any experimental agents within 30 days prior to Visit 1
- •6\. Participation in any other interventional clinical trial during the trial period
- •7\. Significant Medical history
- •8\. Abnormal blood levels
- •9\. Subjects known or suspected of not being able to comply with the trial\-related procedures
Outcomes
Primary Outcomes
Not specified
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