Safety and Efficacy of CRD007 in Adult Asthma Subjects

R

RSPR Pharma

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: CRD007
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02615080
RSPR-008

Details and patient eligibility

About

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 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.

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

168 participants in 2 patient groups, including a placebo group

CRD007
Active Comparator group
Description:
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
Treatment:
Drug: CRD007
Placebo
Placebo Comparator group
Description:
Matching placebo tablets given given twice daily for 14 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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