RSPR-007 Mannitol Challenge Trial

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2015

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.

Interventions

  • Drug: CRD007
    • One single dose given 3 hours prior to Mannitol challenge
  • Other: Placebo
    • One single dose given 3 hours prior to Mannitol challenge

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Matching placebo tables are given as a single dose
  • Active Comparator: CRD007 Low dose
    • “Low dose” of CRD007 (pemirolast sodium) given as a single dose
  • Active Comparator: CRD007 High dose
    • “High dose” CRD007 (pemirolast sodium) given as a single dose

Clinical Trial Outcome Measures

Primary Measures

  • PD15 for mannitol after treatment with CRD007 and placebo
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RSPR Pharma AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vibeke Backer, MD, Principal Investigator, Bispebjerg Hospital

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