Safety and Efficacy of CRD007 in Adult Asthma Subjects

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