Clinical trial NCT01057927: Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Official title: Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Oxagen Ltd
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.


Eligibility criteria: Inclusion Criteria At Screening:

* Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
* Non smokers
* Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
* History of asthma symptoms increasing in response to external allergens.
* Testing positive on skin prick test to an allergen associated with the subject's asthma

Exclusion Criteria:

* Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
* Receipt of prescribed or over the counter medication within 14 days of the first study day.

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 28 days
Secondary outcomes:
measure: Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))
timeFrame: 28 days
measure: Sputum eosinophilia (subset of patients) and serum IgE
timeFrame: 28 days
measure: Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters
timeFrame: 28 days
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Hospital #1
city: Moscow
country: Russian Federation
facility: Research Institute of Pulmonology
city: Moscow
country: Russian Federation
facility: Burdenko Main Military Hospital
city: Moscow
country: Russian Federation
facility: City Hospital #23
city: Moscow
country: Russian Federation
facility: City Hospital #7
city: Moscow
country: Russian Federation
facility: Vishnevsky Central Military Hospital #3
city: St Petersbrug
country: Russian Federation
facility: Leningrad Regional Hospital
city: St Petersbrug
country: Russian Federation
facility: St George City Hospital
city: St Petersburg
country: Russian Federation
facility: St Petersburg Medical Academy of Postgraduate Education
city: St Petersburg
country: Russian Federation
facility: St Petersburg Medical Academy
city: St Petersburg
country: Russian Federation
facility: Outpatient Clinic #94
city: St Petersburg
country: Russian Federation
facility: St Petersbrug Hospital of the Russian Academy of Science
city: St Petersburg
country: Russian Federation
facility: Russian Center of Emergency and Radiology Medicine
city: St Petersburg
country: Russian Federation
facility: St Petersburg State Pediatrics Academy
city: St Petersburg
country: Russian Federation
facility: Central Medical Unit #122
city: St Petersburg
country: Russian Federation
facility: St George City Hospital
Study officials:
References:
citation: Barnes N, Pavord I, Chuchalin A, Bell J, Hunter M, Lewis T, Parker D, Payton M, Collins LP, Pettipher R, Steiner J, Perkins CM. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma. Clin Exp Allergy. 2012 Jan;42(1):38-48. doi: 10.1111/j.1365-2222.2011.03813.x. Epub 2011 Jul 15.