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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260753
• Other study ID #: PPh/00071/10
• Secondary ID: 2010-021858-20
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2010
• Last updated: April 14, 2011
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: Palau Pharma S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• UR-63325
UR-63325
• Fluticasone propionate nasal spray
Fluticasone propionate nasal spray
• Placebo
Placebo to UR 63325 and fluticasone propionate nasal spray

Locations

Country	Name	City	State
Germany	Parexel International GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Palau Pharma S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal and ocular symptoms scores after nasal allergen challenge		24 hours	No
Secondary	Inflammatory parameters measured from nasal exudate		24 hours	No