A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

A Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448902
• Other study ID #: OC000459/007/06
• Secondary ID: 2007-000017-11
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2011
• Last updated: October 6, 2011
• Start date: March 2007
• Est. completion date: May 2007

Study information

• Verified date: October 2011
• Source: Oxagen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.

• Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.

• FEV1 within normal limits (=90% of predicted).

• Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.

• Asymptomatic at screening

• Non smokers for at least the past 12 months

Exclusion Criteria:

• Medical conditions likely to affect the outcome of the study.

• Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.

• Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function

• Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• OC000459
OC000459 200mg bid for 8 days
• Placebo
Placebo bid for 8 days

Locations

Country	Name	City	State
Austria	Vienna Challenge Chamber	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Oxagen Ltd

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score	To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score	8 days	No
Secondary	OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs	To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.	8 days	Yes
Secondary	OC000459 plasma concentration (Cmin)	To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).	8 days	No