OC000459 Bronchial Allergen Challenge

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056692
• Other study ID #: OC000459/004/05
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2009
• Last updated: January 25, 2010
• Start date: February 2006

Study information

• Verified date: January 2010
• Source: Oxagen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• OC000459
Capsules twice daily for 15 days
• Placebo
Capsules twice daily for 15 days

Locations

Country	Name	City	State
United Kingdom	King's College London School of Medicine	London
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Oxagen Ltd	King's College Hospital NHS Trust, Medicines Evaluation Unit, Manchester, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Primary outcome is measured after 15 days of treatment with active or placebo	No
Secondary	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.		These measures are examined after 15 days of treatment with either active or placebo	No