Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

NCT02560610 | Completed Phase 2 DMC

• 2 other identifiers: OC000459/019/152015-001833-26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

OC000459

ACTIVE COMPARATOR

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

Drug: OC000459

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OC000459 DRUG

OC000459

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead
• Atopix Therapeutics, Ltd.: collaborator

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, United Kingdom

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Pulmonary Eosinophilia

Interventions

(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ian Pavord, Professor

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2016
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)