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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02615080

Enrollment

168

Registered

2015-11-25

Start date

2015-11-30

Completion date

2017-02-24

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGCRD007

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Bulgaria, Denmark, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026