RSPR-007 Mannitol Challenge Trial

RSPR Pharma

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: CRD007; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02609334

RSPR-007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo tables are given as a single dose

Treatment:

Other: Placebo

CRD007 Low dose

Active Comparator group

Description:

"Low dose" of CRD007 (pemirolast sodium) given as a single dose

Treatment:

Drug: CRD007

CRD007 High dose

Active Comparator group

Description:

"High dose" CRD007 (pemirolast sodium) given as a single dose

Treatment:

Drug: CRD007