Clinical trial NCT02615080: Safety and Efficacy of CRD007 in Adult Asthma Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: RSPR Pharma AB
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ICS dose
timeFrame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
Secondary outcomes:
Other outcomes:
Locations:
city: Dupnitsa
country: Bulgaria
facility: MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
city: Pazardzhik
country: Bulgaria
facility: SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
city: Razgrad
country: Bulgaria
facility: Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
city: Smolyan
country: Bulgaria
facility: Medical Center Smolyan OOD, Office of Clinical Allergology
city: Sofia
country: Bulgaria
facility: First MHAT - Sofia EAD, Third Department of Internal Medicine
city: Sofia
country: Bulgaria
facility: MHAT Lyulin EAD, Department of Internal Medicine
city: Vratza
country: Bulgaria
facility: SHATPPD Vratsa Ltd, Department of Pneumology
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: København NV
country: Denmark
facility: Bisbebjerg Hospital
city: Næstved
country: Denmark
facility: Næstved Sygehus, Lungemedinsk afdeling
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI-House Sp. Z O.O.
city: Katowice
country: Poland
facility: Medica Pro Familia
city: Kraków
country: Poland
facility: NZOZ Centrum Medcyczne ProMiMed
city: Krákow
country: Poland
facility: Medica Pro Familia
city: Lublin
country: Poland
facility: Clinical Best Solution
city: Poznan
country: Poland
facility: NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
city: Warszawa
country: Poland
facility: Medica Pro Familia
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporów
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit (MEU) Ltd
city: Northwood
country: United Kingdom
facility: Medinova North London Clinical Studies Center
city: Romford
country: United Kingdom
facility: Medinova East London Clinical Studies Centre
city: Sidcup
country: United Kingdom
facility: Medinova South London Clinical Studies Centre
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, MD
role: PRINCIPAL_INVESTIGATOR
References: