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

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Fluticasone propionate nasal spray; Drug: UR-63325; Drug: Placebo

• Registration Number: NCT01260753
• Lead Sponsor: Palau Pharma S.L.U.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluticasone propionate nasal spray	Fluticasone propionate nasal spray	-
UR-63325	UR-63325	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Nasal and ocular symptoms scores after nasal allergen challenge	24 hours

Secondary Outcome Measures

Name	Time	Method
Inflammatory parameters measured from nasal exudate	24 hours

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany