Safety and Efficacy of CRD007 in Adult Asthma Subjects
- Registration Number
- NCT02615080
- Lead Sponsor
- RSPR Pharma AB
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo tablets given given twice daily for 14 weeks CRD007 CRD007 CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
- Primary Outcome Measures
Name Time Method Change in ICS dose Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
🇧🇬Dupnitsa, Bulgaria
SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
🇧🇬Pazardzhik, Bulgaria
Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
🇧🇬Razgrad, Bulgaria
Medical Center Smolyan OOD, Office of Clinical Allergology
🇧🇬Smolyan, Bulgaria
First MHAT - Sofia EAD, Third Department of Internal Medicine
🇧🇬Sofia, Bulgaria
MHAT Lyulin EAD, Department of Internal Medicine
🇧🇬Sofia, Bulgaria
SHATPPD Vratsa Ltd, Department of Pneumology
🇧🇬Vratza, Bulgaria
Centrum Badań Klinicznych PI-House Sp. Z O.O.
🇵🇱Gdańsk, Poland
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Regionshospitalet Silkeborg
🇩🇰Silkeborg, Denmark
Medica Pro Familia
🇵🇱Warszawa, Poland
Clinical Best Solution
🇵🇱Lublin, Poland
Centrum Medyczne Oporów
🇵🇱Wroclaw, Poland
NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
🇵🇱Poznan, Poland
The Medicines Evaluation Unit (MEU) Ltd
🇬🇧Manchester, United Kingdom
Medinova North London Clinical Studies Center
🇬🇧Northwood, United Kingdom
Medinova East London Clinical Studies Centre
🇬🇧Romford, United Kingdom
Medinova South London Clinical Studies Centre
🇬🇧Sidcup, United Kingdom
Bisbebjerg Hospital
🇩🇰København NV, Denmark
Næstved Sygehus, Lungemedinsk afdeling
🇩🇰Næstved, Denmark
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
NZOZ Centrum Medcyczne ProMiMed
🇵🇱Kraków, Poland