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NCT Number: NCT00890877

OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.

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Key information

Conditions

Mild to Moderate Persistent Asthma 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

Research site, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
  • Aged 18 to 55 years inclusive.
  • Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
  • Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months

Exclusion criteria

  • Receipt of prescribed or over the counter medication within 14 days prior to the first study day

Treatment and study plan

OC000459 or placebo

Drug

Pills, active and/or placebo given twice daily for 17 weeks

Primary outcomes

  1. Forced expiratory volume in one second (FEV1)

    Time frame: 17 weeks

Secondary outcomes

  1. Asthma quality of life questionnaire (AQLQ)

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

Oxagen Ltd

Industry

Registry information

Official study title

Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2009
Registry last updated
Sep 2, 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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