Investigation of CRD007 in asthma patients

Phase 1

Conditions: Asthma
MedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2015-002656-26-DK

Lead Sponsor: RSPR Pharma AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. Written informed consent must be obtained before any trial related procedures are performed
2. Age =18 years old
3. Diagnosis of asthma according to GINA Guidelines (1)
4. Atopic phenotype
5. Treated with ICS and LABA for at least 12 weeks prior to Visit 1
6. Blood eosinophils =0.05*109/L at Visit 1
7. Demonstration of FEV1 at Visit 1 = 60% of the predicted value
8. Demonstration of ACQ6 = 0.5 and =2.5 at Visit 1
9. Reversibility demonstrated at Visit 1 or 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Lower respiratory tract infection <6 weeks prior to Visit 1
2. Smokers
3. Treatment with disallowed medication
4. Pregnant and breast-feeding female subjects
5. Receipt of any experimental agents within 30 days prior to Visit 1
6. Participation in any other interventional clinical trial during the trial period
7. Significant Medical history
8. Abnormal blood levels
9. Subjects known or suspected of not being able to comply with the trial-related procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of 200 mg CRD007 administered orally b.i.d. on asthma control during tapering of a background therapy of standard asthma controller medication (ICS and LABA).;Secondary Objective: •Treatment failure e.g:<br>o Subject is withdrawn <br>o Worsening of asthma <br>oSubject does not fulfil criteria for reduced ICS dose <br>•Safety profile of CRD007 <br>;Primary end point(s): Average dose of (Inhaled corticosteroids) ICS;Timepoint(s) of evaluation of this end point: From Visit 5 to Visit 10.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Treatment failure from randomization e.g:<br>o Subject is withdrawn <br>o Worsening of asthma <br>oSubject does not fulfil criteria for reduced ICS dose <br>•Safety profile of CRD007 <br>;Timepoint(s) of evaluation of this end point: From visit 3 to visit 11 <br>