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Safety and Efficacy of CRD007 in Adult Asthma Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615080
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
RSPR Pharma AB

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date February 27, 2017
Actual Study Start Date  ICMJE November 30, 2015
Actual Primary Completion Date February 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
Change in ICS dose [ Time Frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of CRD007 in Adult Asthma Subjects
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: CRD007
    Other Name: Pemirolast sodium
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: CRD007
    CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
    Intervention: Drug: CRD007
  • Placebo Comparator: Placebo
    Matching placebo tablets given given twice daily for 14 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2016)
168
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
200
Actual Study Completion Date  ICMJE February 24, 2017
Actual Primary Completion Date February 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Denmark,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02615080
Other Study ID Numbers  ICMJE RSPR-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RSPR Pharma AB
Study Sponsor  ICMJE RSPR Pharma AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vibeke Backer, MD Bispebjerg Hospital
PRS Account RSPR Pharma AB
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP