OC000459 Dose Finding Study in Hay Fever Sufferers.

Allergic Rhinitis Clinical Trial

Official title:

A Dose Finding 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: NCT00697281
• Other study ID #: OC000459/010/07
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: February 23, 2009
• Start date: May 2008
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• 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 primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

Description:

This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

• Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.

• Acceptable contraception includes the use of TWO of the following:

• oral contraception (i.e. the Pill);

• intrauterine device (an IUD or 'Coil');

• barrier contraception (i.e. condoms or diaphragm/cap);

• transdermal patch

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 as determined by the principal investigator or designee.

• Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 = 90% predicted for height and age).

• Immunotherapy treatment course in the past 28 days

• Use of inhaled or local corticosteroids in the past 28 days.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• OC000459
Tablets twice daily for 8 days Dose level 1
• OC000459
Tablets twice daily for 8 days Dose level 2
• OC000459
Tablets twice daily for 8 days Dose level 3
• OC000459
Tablets twice daily for 8 days Dose level 4
• Placebo
Tablets twice daily for 8 days Dose level 5

Locations

Country	Name	City	State
Austria	Allergie Zentrum Wien West, 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	Total nasal symptom score (TNSS)		After 8 days of treatment	No
Secondary	Other symptom scores of allergic rhinitis		After 8 days of treatment	No