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Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

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ClinicalTrials.gov Identifier: NCT02560610
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Atopix Therapeutics, Ltd.

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.

Condition or disease Intervention/treatment Phase
Severe Eosinophilic Asthma Drug: OC000459 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560610


Locations
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United Kingdom
University of Oxford
Oxford, Oxfordshire, United Kingdom
Sponsors and Collaborators
Atopix Therapeutics, Ltd.
Investigators
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Principal Investigator: Ian Pavord, Professor University of Oxford

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Responsible Party: Atopix Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT02560610     History of Changes
Other Study ID Numbers: OC000459/019/15
2015-001833-26 ( EudraCT Number )
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Asthma
Pulmonary Eosinophilia
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs