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OC000459 Dose Finding Study in Hay Fever Sufferers.

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

OC000459

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis, human, clinical trial, efficacy, safety, challenge test

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Allergie Zentrum Wien West, Vienna Challenge Chamber

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Arm Description

Dose level 1

Dose level 2

Dose level 3

Dose level 4

Dose level 5

Outcomes

Primary Outcome Measures

Total nasal symptom score (TNSS)

Secondary Outcome Measures

Other symptom scores of allergic rhinitis

Full Information

NCT ID

NCT00697281

First Posted

June 11, 2008

Last Updated

February 23, 2009

Sponsor

Oxagen Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00697281

Brief Title

OC000459 Dose Finding Study in Hay Fever Sufferers.

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Oxagen Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

allergic rhinitis, human, clinical trial, efficacy, safety, challenge test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Dose level 1

Arm Title

Arm Type

Experimental

Arm Description

Dose level 2

Arm Title

Arm Type

Experimental

Arm Description

Dose level 3

Arm Title

Arm Type

Experimental

Arm Description

Dose level 4

Arm Title

Arm Type

Experimental

Arm Description

Dose level 5

Intervention Type

Drug

Intervention Name(s)

OC000459

Intervention Description

Tablets twice daily for 8 days Dose level 1

Intervention Type

Drug

Intervention Name(s)

OC000459

Intervention Description

Tablets twice daily for 8 days Dose level 2

Intervention Type

Drug

Intervention Name(s)

OC000459

Intervention Description

Tablets twice daily for 8 days Dose level 3

Intervention Type

Drug

Intervention Name(s)

OC000459

Intervention Description

Tablets twice daily for 8 days Dose level 4

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablets twice daily for 8 days Dose level 5

Primary Outcome Measure Information:

Title

Total nasal symptom score (TNSS)

Time Frame

After 8 days of treatment

Secondary Outcome Measure Information:

Title

Other symptom scores of allergic rhinitis

Time Frame

After 8 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Univ Prof. Dr. Friedrich Horak, MD

Organizational Affiliation

Allergie Zentrum Wien West

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allergie Zentrum Wien West, Vienna Challenge Chamber

City

Vienna

ZIP/Postal Code

1150 VIENNA

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

OC000459 Dose Finding Study in Hay Fever Sufferers.

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