RSPR-007 Mannitol Challenge Trial

Study Overview
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Brief Summary
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This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.

Detailed Description
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The present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. Mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways. The trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from Visit 2 (Randomisation) to Visit 5 (Follow up). Visit 2,3, and 4 will be treatment visits where Investigational Medicinal Product (IMP) is administrated 3 hours before the Mannitol challenge.

Official Title
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A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the Efficacy of CRD007 in Adult Subjects With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: CRD007
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age ≥18 and <50 years Diagnosis of asthma Exclusion Criteria: Clinical significant comorbidities Lower respiratory tract infection <6 weeks prior to Visit 1 Others, as specified in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching placebo tables are given as a single dose | Other: Placebo<br>* One single dose given 3 hours prior to Mannitol challenge<br>|
| Active Comparator: CRD007 Low dose<br>Low dose of CRD007 (pemirolast sodium) given as a single dose | Drug: CRD007<br>* One single dose given 3 hours prior to Mannitol challenge<br>* Other names: Pemirolast sodium;|
| Active Comparator: CRD007 High dose<br>High dose CRD007 (pemirolast sodium) given as a single dose | Drug: CRD007<br>* One single dose given 3 hours prior to Mannitol challenge<br>* Other names: Pemirolast sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD15 for mannitol after treatment with CRD007 and placebo | The FEV1 value taken after the 0 mg capsule is taken as pre-challenge FEV1 and used to calculate the percentage decrease in FEV1 in response to the mannitol challenge. The test ends when the FEV1 has fallen by 15% or more (PD15) | Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose |