Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge

NCT ID: NCT01260753

Last Updated: 2011-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

UR-63325

Group Type: EXPERIMENTAL

UR-63325

Intervention Type: DRUG

UR-63325

Fluticasone propionate nasal spray

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate nasal spray

Intervention Type: DRUG

Fluticasone propionate nasal spray

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to UR 63325 and fluticasone propionate nasal spray

Interventions

UR-63325

UR-63325

Intervention Type: DRUG

Fluticasone propionate nasal spray

Fluticasone propionate nasal spray

Intervention Type: DRUG

Placebo

Placebo to UR 63325 and fluticasone propionate nasal spray

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
• Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
• Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
• Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score [TNSS]) within one hour after last nasal allergen challenge
• Screening and baseline FEV1 >80% predicted and FEV1/FVC > 70% predicted

Exclusion Criteria

• Symptoms of allergic rhinitis within 2 weeks prior to screening
• Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
• Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
• History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1<80% of predicted at screening or baseline

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Palau Pharma S.L.U.

INDUSTRY

Sponsor Role: lead

Responsible Party

Palau Pharma S.A.

Principal Investigators

Rainard Fuhr, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Parexel International GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

2010-021858-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PPh/00071/10

Identifier Type: -

Identifier Source: org_study_id