Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRD007 | Active Comparator | CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks |
|
| Placebo | Placebo Comparator | Matching placebo tablets given given twice daily for 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRD007 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ICS dose | Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vibeke Backer, MD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine | Dupnitsa | 2600 | Bulgaria | |||
| SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Pazardzhik |
| 4400 |
| Bulgaria |
| Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry | Razgrad | 7200 | Bulgaria |
| Medical Center Smolyan OOD, Office of Clinical Allergology | Smolyan | 4700 | Bulgaria |
| First MHAT - Sofia EAD, Third Department of Internal Medicine | Sofia | 1000 | Bulgaria |
| MHAT Lyulin EAD, Department of Internal Medicine | Sofia | 1336 | Bulgaria |
| SHATPPD Vratsa Ltd, Department of Pneumology | Vratsa | 3000 | Bulgaria |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Bisbebjerg Hospital | København NV | 2400 | Denmark |
| Næstved Sygehus, Lungemedinsk afdeling | Næstved | 4700 | Denmark |
| Regionshospitalet Silkeborg | Silkeborg | 8600 | Denmark |
| Centrum Badań Klinicznych PI-House Sp. Z O.O. | Gdansk | 80-546 | Poland |
| Medica Pro Familia | Katowice | 40-954 | Poland |
| NZOZ Centrum Medcyczne ProMiMed | Krakow | 31-637 | Poland |
| Medica Pro Familia | Krákow | 30-002 | Poland |
| Clinical Best Solution | Lublin | 20-045 | Poland |
| NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska | Poznan | 60-823 | Poland |
| Medica Pro Familia | Warsaw | 01-868 | Poland |
| Centrum Medyczne Oporów | Wroclaw | 52-416 | Poland |
| The Medicines Evaluation Unit (MEU) Ltd | Manchester | M23 9QZ | United Kingdom |
| Medinova North London Clinical Studies Center | Northwood | HA6 2RN | United Kingdom |
| Medinova East London Clinical Studies Centre | Romford | RM1 3LT | United Kingdom |
| Medinova South London Clinical Studies Centre | Sidcup | DA14 6LT | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided