OC000459 Dose Finding Study in Hay Fever Sufferers. - Full Text View

Purpose

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

Condition	Intervention	Phase
Allergic Rhinitis	Drug: OC000459 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Fever

U.S. FDA Resources

Further study details as provided by Oxagen Ltd:

Primary Outcome Measures:

Total nasal symptom score (TNSS) [ Time Frame: After 8 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other symptom scores of allergic rhinitis [ Time Frame: After 8 days of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2008
Study Completion Date:	September 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Dose level 1	Drug: OC000459 Tablets twice daily for 8 days Dose level 1
Experimental: 2 Dose level 2	Drug: OC000459 Tablets twice daily for 8 days Dose level 2
Experimental: 3 Dose level 3	Drug: OC000459 Tablets twice daily for 8 days Dose level 3
Experimental: 4 Dose level 4	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697281

Locations

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

Sponsors and Collaborators

Oxagen Ltd

Investigators

Principal Investigator:

Univ Prof. Dr. Friedrich Horak, MD

Allergie Zentrum Wien West

More Information

No publications provided

Responsible Party:	Dr C Mike Perkins, Oxagen Ltd
ClinicalTrials.gov Identifier:	NCT00697281 History of Changes
Other Study ID Numbers:	OC000459/010/07
Study First Received:	June 11, 2008
Last Updated:	February 23, 2009
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Oxagen Ltd:

allergic rhinitis
human
clinical trial

efficacy
safety
challenge test

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 13, 2013