OC000459 Dose Finding Study in Hay Fever Sufferers.

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.

The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: OC000459; Drug: OC000459; Drug: OC000459; Drug: OC000459; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1150 VIENNA
    • Allergie Zentrum Wien West, Vienna Challenge Chamber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dose level 1	Drug: OC000459; Tablets twice daily for 8 days Dose level 1; Drug: OC000459; Tablets twice daily for 8 days Dose level 2; Drug: OC000459; Tablets twice daily for 8 days Dose level 3; Drug: OC000459; Tablets twice daily for 8 days Dose level 4
Experimental: 2; Dose level 2	Drug: OC000459; Tablets twice daily for 8 days Dose level 1; Drug: OC000459; Tablets twice daily for 8 days Dose level 2; Drug: OC000459; Tablets twice daily for 8 days Dose level 3; Drug: OC000459; Tablets twice daily for 8 days Dose level 4
Experimental: 3; Dose level 3	Drug: OC000459; Tablets twice daily for 8 days Dose level 1; Drug: OC000459; Tablets twice daily for 8 days Dose level 2; Drug: OC000459; Tablets twice daily for 8 days Dose level 3; Drug: OC000459; Tablets twice daily for 8 days Dose level 4
Experimental: 4; Dose level 4	Drug: OC000459; Tablets twice daily for 8 days Dose level 1; Drug: OC000459; Tablets twice daily for 8 days Dose level 2; Drug: OC000459; Tablets twice daily for 8 days Dose level 3; Drug: OC000459; Tablets twice daily for 8 days Dose level 4
Experimental: 5; Dose level 5	Drug: Placebo; Tablets twice daily for 8 days Dose level 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total nasal symptom score (TNSS)	After 8 days of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Other symptom scores of allergic rhinitis	After 8 days of treatment

Collaborators and Investigators

• Sponsor: Oxagen Ltd
• Investigators: Principal Investigator: Univ Prof. Dr. Friedrich Horak, MD, Allergie Zentrum Wien West

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 12, 2008
• First Posted (Estimate): June 13, 2008

Study Record Updates

• Last Update Posted (Estimate): February 24, 2009
• Last Update Submitted That Met QC Criteria: February 23, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: safety; clinical trial; efficacy; human; allergic rhinitis; challenge test
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Growth Substances; Plant Growth Regulators; Indoleacetic Acids
• Other Study ID Numbers: OC000459/010/07