NCT02609334

RSPR-007 Mannitol Challenge Trial

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: RSPR Pharma AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CRD007	One single dose given 3 hours prior to Mannitol challenge
OTHER	Placebo	One single dose given 3 hours prior to Mannitol challenge

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-11-20
• Last updated: 2016-11-16

Locations

2 sites across 1 country: Denmark