RSPR-007 Mannitol Challenge Trial

Phase 2

Completed

• Conditions: Asthma
• Interventions: Other: Placebo; Drug: CRD007

• Registration Number: NCT02609334
• Lead Sponsor: RSPR Pharma AB

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-11
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tables are given as a single dose
CRD007 Low dose	CRD007	"Low dose" of CRD007 (pemirolast sodium) given as a single dose
CRD007 High dose	CRD007	"High dose" CRD007 (pemirolast sodium) given as a single dose

Primary Outcome Measures

Name	Time	Method
PD15 for mannitol after treatment with CRD007 and placebo	Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose	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)

Trial Locations

Locations (2)

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Bisbebjerg Hospital; 🇩🇰 København NV, Denmark