Safety and Efficacy of CRD007 in Adult Asthma Subjects

• Status: Completed
• Trial end date: 2017-02-24
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RSPR Pharma AB
• Treatments: Pemirolast

Criteria

Inclusion Criteria:

• Written informed consent

• Age ≥18 years old

• Diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines

• Atopic phenotype as assessed by the investigator

• Treated with ICS and LABA for at least 12 weeks prior to Visit 1with protocol defined daily doses

• Blood eosinophils ≥0.15*109/L at Visit 1

• Demonstration of forced expiratory volume at one second (FEV1) >60% of the predicted value at Visit 1

• Demonstration of ACQ6 ≥ 0.5 and ≤1.5 at Visit 1

• Reversibility of at least 12% and 200 mL in FEV1

Exclusion Criteria:

• Lower respiratory tract infection <6 weeks prior to Visit 1

• Current smokers

• Significant concurrent, uncontrolled medical condition as defined by the protocol

• Others, as defined in the protocol