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Safety and Efficacy of CRD007 in Adult Asthma Subjects

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CRD007
Placebo
Sponsored by
RSPR Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
  • SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
  • Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
  • Medical Center Smolyan OOD, Office of Clinical Allergology
  • First MHAT - Sofia EAD, Third Department of Internal Medicine
  • MHAT Lyulin EAD, Department of Internal Medicine
  • SHATPPD Vratsa Ltd, Department of Pneumology
  • Aalborg Universitetshospital
  • Hvidovre Hospital
  • Bisbebjerg Hospital
  • Næstved Sygehus, Lungemedinsk afdeling
  • Regionshospitalet Silkeborg
  • Centrum Badań Klinicznych PI-House Sp. Z O.O.
  • Medica Pro Familia
  • NZOZ Centrum Medcyczne ProMiMed
  • Medica Pro Familia
  • Clinical Best Solution
  • NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
  • Medica Pro Familia
  • Centrum Medyczne Oporów
  • The Medicines Evaluation Unit (MEU) Ltd
  • Medinova North London Clinical Studies Center
  • Medinova East London Clinical Studies Centre
  • Medinova South London Clinical Studies Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CRD007

Placebo

Arm Description

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

Matching placebo tablets given given twice daily for 14 weeks

Outcomes

Primary Outcome Measures

Change in ICS dose

Secondary Outcome Measures

Full Information

First Posted
November 17, 2015
Last Updated
February 24, 2017
Sponsor
RSPR Pharma AB
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1. Study Identification

Unique Protocol Identification Number
NCT02615080
Brief Title
Safety and Efficacy of CRD007 in Adult Asthma Subjects
Official Title
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
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
February 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RSPR Pharma AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRD007
Arm Type
Active Comparator
Arm Description
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets given given twice daily for 14 weeks
Intervention Type
Drug
Intervention Name(s)
CRD007
Other Intervention Name(s)
Pemirolast sodium
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in ICS dose
Time Frame
Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke Backer, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
Medical Center Smolyan OOD, Office of Clinical Allergology
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
First MHAT - Sofia EAD, Third Department of Internal Medicine
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
MHAT Lyulin EAD, Department of Internal Medicine
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
SHATPPD Vratsa Ltd, Department of Pneumology
City
Vratza
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Bisbebjerg Hospital
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Næstved Sygehus, Lungemedinsk afdeling
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Regionshospitalet Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Centrum Badań Klinicznych PI-House Sp. Z O.O.
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Medica Pro Familia
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
NZOZ Centrum Medcyczne ProMiMed
City
Kraków
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Medica Pro Familia
City
Krákow
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Clinical Best Solution
City
Lublin
ZIP/Postal Code
20-045
Country
Poland
Facility Name
NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
City
Poznan
ZIP/Postal Code
60-823
Country
Poland
Facility Name
Medica Pro Familia
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Centrum Medyczne Oporów
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
The Medicines Evaluation Unit (MEU) Ltd
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
Medinova North London Clinical Studies Center
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Medinova East London Clinical Studies Centre
City
Romford
ZIP/Postal Code
RM1 3LT
Country
United Kingdom
Facility Name
Medinova South London Clinical Studies Centre
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom

12. IPD Sharing Statement

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Safety and Efficacy of CRD007 in Adult Asthma Subjects

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