Clinical trial NCT02560610: Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma
Official title: The Effect of OC000459 on Eosinophilic Airway Inflammation and Asthma Control in Subjects With Refractory Eosinophilic Asthma: a Randomised, Double-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Eosinophilic Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Atopix Therapeutics, Ltd.
First posted: 2015-09-25
Enrollment: 40
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: 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.

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.

Primary outcomes:
measure: Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts.
timeFrame: Mean change from baseline and week 12
Secondary outcomes:
measure: The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1).
timeFrame: Every 4 weeks up to week 12
measure: The effect of OC000459 on fractional exhaled nitric oxide (FeNO).
timeFrame: At 4,8 and 12 weeks
measure: Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)).
timeFrame: At weeks 4,8 and 12
measure: Statistical comparison from baseline on induced sputum eosinophil count.
timeFrame: At weeks 4,8 and 12
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Ian Pavord, Professor
role: PRINCIPAL_INVESTIGATOR
References: