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

Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Collaborator: Atopix Therapeutics, Ltd.

Source Chiesi Farmaceutici S.p.A.
Brief Summary

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

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.

Overall Status Completed
Start Date September 2016
Completion Date August 2, 2018
Primary Completion Date August 2, 2018
Phase Phase 2
Study Type Interventional
Primary 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
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
Enrollment 40
Condition
Intervention

Intervention type: Drug

Intervention name: OC000459

Arm group label: OC000459

Intervention type: Drug

Intervention name: Placebo

Arm group label: Placebo

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ian Pavord, Professor Principal Investigator University of Oxford
Location
facility University of Oxford
Location Countries

United Kingdom

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: OC000459

Arm group type: Active Comparator

Description: Once daily dose of 50mg OC000459 tablets orally for 12/24 weeks

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Once daily dose of placebo tablets orally for 12/24 weeks

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov