NCT02615080

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Nov 2015

Geographic Reach
4 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 30, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

November 17, 2015

Last Update Submit

February 24, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change in ICS dose

    Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)

Study Arms (2)

CRD007

ACTIVE COMPARATOR

CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks

Drug: CRD007

Placebo

PLACEBO COMPARATOR

Matching placebo tablets given given twice daily for 14 weeks

Drug: Placebo

Interventions

CRD007DRUG
Also known as: Pemirolast sodium
CRD007
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine

Dupnitsa, 2600, Bulgaria

Location

SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics

Pazardzhik, 4400, Bulgaria

Location

Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry

Razgrad, 7200, Bulgaria

Location

Medical Center Smolyan OOD, Office of Clinical Allergology

Smolyan, 4700, Bulgaria

Location

First MHAT - Sofia EAD, Third Department of Internal Medicine

Sofia, 1000, Bulgaria

Location

MHAT Lyulin EAD, Department of Internal Medicine

Sofia, 1336, Bulgaria

Location

SHATPPD Vratsa Ltd, Department of Pneumology

Vratsa, 3000, Bulgaria

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Bisbebjerg Hospital

København NV, 2400, Denmark

Location

Næstved Sygehus, Lungemedinsk afdeling

Næstved, 4700, Denmark

Location

Regionshospitalet Silkeborg

Silkeborg, 8600, Denmark

Location

Centrum Badań Klinicznych PI-House Sp. Z O.O.

Gdansk, 80-546, Poland

Location

Medica Pro Familia

Katowice, 40-954, Poland

Location

NZOZ Centrum Medcyczne ProMiMed

Krakow, 31-637, Poland

Location

Medica Pro Familia

Krákow, 30-002, Poland

Location

Clinical Best Solution

Lublin, 20-045, Poland

Location

NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska

Poznan, 60-823, Poland

Location

Medica Pro Familia

Warsaw, 01-868, Poland

Location

Centrum Medyczne Oporów

Wroclaw, 52-416, Poland

Location

The Medicines Evaluation Unit (MEU) Ltd

Manchester, M23 9QZ, United Kingdom

Location

Medinova North London Clinical Studies Center

Northwood, HA6 2RN, United Kingdom

Location

Medinova East London Clinical Studies Centre

Romford, RM1 3LT, United Kingdom

Location

Medinova South London Clinical Studies Centre

Sidcup, DA14 6LT, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Vibeke Backer, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 25, 2015

Study Start

November 30, 2015

Primary Completion

February 21, 2017

Study Completion

February 24, 2017

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

GB(4)BU(7)DK(5)PL(8)