Safety and Efficacy of CRD007 in Adult Asthma Subjects

Overview

This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.

Full Title of Study: “A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects With Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 21, 2017

Detailed Description

The present trial will include subjects with diagnosed asthma. The trial involves a total of 11 visits (Visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit). The subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled. Between visits to the clinic the subjects have to complete a diary.

Interventions

  • Drug: CRD007
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: CRD007
    • CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
  • Placebo Comparator: Placebo
    • Matching placebo tablets given given twice daily for 14 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in ICS dose
    • Time Frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent – Age ≥18 years old – Diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines – Atopic phenotype as assessed by the investigator – Treated with ICS and LABA for at least 12 weeks prior to Visit 1with protocol defined daily doses – Blood eosinophils ≥0.15*109/L at Visit 1 – Demonstration of forced expiratory volume at one second (FEV1) >60% of the predicted value at Visit 1 – Demonstration of ACQ6 ≥ 0.5 and ≤1.5 at Visit 1 – Reversibility of at least 12% and 200 mL in FEV1 Exclusion Criteria:

  • Lower respiratory tract infection <6 weeks prior to Visit 1 – Current smokers – Significant concurrent, uncontrolled medical condition as defined by the protocol – Others, as defined in the protocol

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

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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