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Completed

NCT Number: NCT01057927

Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burdenko Main Military Hospital, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OC000459

Drug

OC000459 capsules 2x100mg BID for 28 days

Placebo

Drug

Placebo capsules to match OC000459 100mg capsules, 2 tablets BID

Primary outcomes

  1. Forced expiratory volume in one second (FEV1)

    Time frame: 28 days

Secondary outcomes

  1. Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))

    Time frame: 28 days

  2. Sputum eosinophilia (subset of patients) and serum IgE

    Time frame: 28 days

  3. Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Oxagen Ltd

Industry

Registry information

Official study title

Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 28, 2010
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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