Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

The Effect of OC000459 on Eosinophilic Airway Inflammation and Asthma Control in Subjects With Refractory Eosinophilic Asthma: a Randomised, Double-blind, Placebo Controlled Trial

The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.

Study Overview

• Status: Completed
• Conditions: Severe Eosinophilic Asthma
• Intervention / Treatment: Drug: Placebo; Drug: OC000459

Detailed Description

At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom
      • University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Show evidence of reversible airflow obstruction documented within the previous 12 months or prior to Randomisation.
• Meet the European Respiratory Society/American Thoracic Society (ERS/ATS) criteria for severe asthma at Screening.
• Have documented evidence of eosinophilic airway inflammation during the 12 months prior to Screening.
• Have evidence of eosinophilic airway inflammation at Screening as reflected by an induced sputum eosinophil count of ≥3%.
• Subjects who are taking oral corticosteroids (OCS) must be receiving a 20 mg prednisolone equivalent dose, or less, daily for at least four weeks before the first dose of study drug. The dose of OCS should be unchanged for at least 14 days prior to the Baseline visit.

Exclusion Criteria:

• Treatment with XolairTM or anti-Th2 biologicals within 6 months prior to screening.
• Subjects with clinically significant abnormal serum biochemistry, haematology and urine examination values
• Subjects who have been hospitalised in the last 3 months.
• History of more than 2 episodes of confirmed bacterial lower respiratory tract infection or current lower respiratory tract infection.
• Subjects are current smokers or have a smoking history of >15 pack years.
• Significant comorbidity that in the Investigator's opinion is likely to impact the subject's participation in a 26 week study.
• Presence of a clinically important lung condition other than asthma, malignancy or previous history of cancer in remission for less than 12 months, clinically important liver or kidney disease, uncontrolled clinically significant cardiovascular disease, hypereosinophilic syndromes such as Churg-Strauss Syndrome or eosinophilic oesophagitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OC000459; Once daily dose of 50mg OC000459 tablets orally for 12/24 weeks	Drug: OC000459
Placebo Comparator: Placebo; Once daily dose of placebo tablets orally for 12/24 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts.	Mean change from baseline and week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1).	Every 4 weeks up to week 12
The effect of OC000459 on fractional exhaled nitric oxide (FeNO).	At 4,8 and 12 weeks
Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)).	At weeks 4,8 and 12
Statistical comparison from baseline on induced sputum eosinophil count.	At weeks 4,8 and 12

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Collaborators: Atopix Therapeutics, Ltd.
• Investigators: Principal Investigator: Ian Pavord, Professor, University of Oxford

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Inflammation; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: OC000459/019/15; 2015-001833-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO