Safety and Efficacy of CRD007 in Adult Asthma Subjects

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615080
• Other study ID #: RSPR-008
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2015
• Last updated: February 24, 2017
• Start date: November 30, 2015
• Est. completion date: February 24, 2017

Study information

• Verified date: February 2017
• Source: RSPR Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 24, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CRD007

• Placebo

Locations

Country	Name	City	State
Bulgaria	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
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Bisbebjerg Hospital	København NV
Denmark	Næstved Sygehus, Lungemedinsk afdeling	Næstved
Denmark	Regionshospitalet Silkeborg	Silkeborg
Poland	Centrum Badan Klinicznych PI-House Sp. Z O.O.	Gdansk
Poland	Medica Pro Familia	Katowice
Poland	NZOZ Centrum Medcyczne ProMiMed	Kraków
Poland	Medica Pro Familia	Krákow
Poland	Clinical Best Solution	Lublin
Poland	NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska	Poznan
Poland	Medica Pro Familia	Warszawa
Poland	Centrum Medyczne Oporów	Wroclaw
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
RSPR Pharma AB

Countries where clinical trial is conducted

Bulgaria,  Denmark,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ICS dose		Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)