Safety and Efficacy of CRD007 in Adult Asthma Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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The present trial will include subjects with diagnosed asthma. The trial involves a total of 11 visits (Visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit). The subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled. Between visits to the clinic the subjects have to complete a diary.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: CRD007
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRD007<br>CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks | Drug: CRD007<br> <br> * Other names: Pemirolast sodium;|
| Placebo Comparator: Placebo<br>Matching placebo tablets given given twice daily for 14 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ICS dose |  | Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18) |