Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2015-11-30
2017-02-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CRD007
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
CRD007
Placebo
Matching placebo tablets given given twice daily for 14 weeks
Placebo
Interventions
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CRD007
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Current smokers
* Significant concurrent, uncontrolled medical condition as defined by the protocol
* Others, as defined in the protocol
18 Years
ALL
No
Sponsors
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RSPR Pharma AB
INDUSTRY
Responsible Party
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Principal Investigators
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Vibeke Backer, MD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
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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
Vratsa, , Bulgaria
Aalborg Universitetshospital
Aalborg, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Bisbebjerg Hospital
København NV, , Denmark
Næstved Sygehus, Lungemedinsk afdeling
Næstved, , Denmark
Regionshospitalet Silkeborg
Silkeborg, , Denmark
Centrum Badań Klinicznych PI-House Sp. Z O.O.
Gdansk, , Poland
Medica Pro Familia
Katowice, , Poland
NZOZ Centrum Medcyczne ProMiMed
Krakow, , Poland
Medica Pro Familia
Krákow, , Poland
Clinical Best Solution
Lublin, , Poland
NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
Poznan, , Poland
Medica Pro Familia
Warsaw, , Poland
Centrum Medyczne Oporów
Wroclaw, , 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
Countries
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Other Identifiers
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RSPR-008
Identifier Type: -
Identifier Source: org_study_id
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