Safety and Efficacy of CRD007 in Adult Asthma Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: CRD007

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
  • Pazardzhik, Bulgaria, 4400
    • SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
  • Razgrad, Bulgaria, 7200
    • Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
  • Smolyan, Bulgaria, 4700
    • Medical Center Smolyan OOD, Office of Clinical Allergology
  • Sofia, Bulgaria, 1000
    • First MHAT - Sofia EAD, Third Department of Internal Medicine
  • Sofia, Bulgaria, 1336
    • MHAT Lyulin EAD, Department of Internal Medicine
  • Vratza, Bulgaria, 3000
    • SHATPPD Vratsa Ltd, Department of Pneumology
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • København NV, Denmark, 2400
    • Bisbebjerg Hospital
  • Næstved, Denmark, 4700
    • Næstved Sygehus, Lungemedinsk afdeling
  • Silkeborg, Denmark, 8600
    • Regionshospitalet Silkeborg
• Poland
  • Gdańsk, Poland, 80-546
    • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Katowice, Poland, 40-954
    • Medica Pro Familia
  • Kraków, Poland, 31-637
    • NZOZ Centrum Medcyczne ProMiMed
  • Krákow, Poland, 30-002
    • Medica Pro Familia
  • Lublin, Poland, 20-045
    • Clinical Best Solution
  • Poznan, Poland, 60-823
    • NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
  • Warszawa, Poland, 01-868
    • Medica Pro Familia
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • The Medicines Evaluation Unit (MEU) Ltd
  • Northwood, United Kingdom, HA6 2RN
    • Medinova North London Clinical Studies Center
  • Romford, United Kingdom, RM1 3LT
    • Medinova East London Clinical Studies Centre
  • Sidcup, United Kingdom, DA14 6LT
    • Medinova South London Clinical Studies Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CRD007; CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks	Drug: CRD007; Other Names: Pemirolast sodium
Placebo Comparator: Placebo; Matching placebo tablets given given twice daily for 14 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RSPR Pharma AB
• Investigators: Principal Investigator: Vibeke Backer, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2015
• Primary Completion (Actual): February 21, 2017
• Study Completion (Actual): February 24, 2017

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Pemirolast
• Other Study ID Numbers: RSPR-008