OC000459 Bronchial Allergen Challenge

This study has been completed.
Sponsor:
Collaborators:
Medicines Evaluation Unit, Manchester, UK
King's College Hospital NHS Trust
Information provided by:
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01056692
First received: December 21, 2009
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.


Condition Intervention Phase
Bronchial Asthma
Drug: OC000459
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Study of oc000459 in Subjects With Allergic Asthma; a Randomised, Double Blind, Two Way Balanced Crossover Comparing oc000459 With Placebo

Resource links provided by NLM:


Further study details as provided by Oxagen Ltd:

Primary Outcome Measures:
  • The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge. [ Time Frame: Primary outcome is measured after 15 days of treatment with active or placebo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge sputum eosinophilia, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen. [ Time Frame: These measures are examined after 15 days of treatment with either active or placebo ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2006
Arms Assigned Interventions
Active Comparator: Active compound
OC000459 orally
Drug: OC000459
Capsules twice daily for 15 days
Placebo Comparator: Placebo
Placebo given orally
Drug: Placebo
Capsules twice daily for 15 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
  • FEV1 >65% of predicted on at least two occasions at screening.
  • At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
  • No steroid usage in the past 12 weeks.
  • Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
  • Non smokers for a minimum of 6 months; less than 10 pack year history.

Exclusion Criteria:

  • Respiratory tract pathology other than allergic asthma.
  • Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
  • Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056692

Locations
United Kingdom
King's College London School of Medicine
London, United Kingdom, SE5 9PJ
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Oxagen Ltd
Medicines Evaluation Unit, Manchester, UK
King's College Hospital NHS Trust
Investigators
Principal Investigator: David Singh, MD Medicines Evaluation Unit, Manchester, UK
  More Information

No publications provided by Oxagen Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr David Singh, Medicines Evaluation Unit, Manchester UK
ClinicalTrials.gov Identifier: NCT01056692     History of Changes
Other Study ID Numbers: OC000459/004/05
Study First Received: December 21, 2009
Last Updated: January 25, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Oxagen Ltd:
Asthma
bronchial allergen challenge
sputum eosinophiilia

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014