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

NCT01260753 | Completed Phase 2

• 2 other identifiers: PPh/00071/102010-021858-20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Nasal and ocular symptoms scores after nasal allergen challenge

  24 hours

Secondary Outcomes (1)

• Inflammatory parameters measured from nasal exudate

  24 hours

Study Arms (3)

UR-63325

EXPERIMENTAL

Drug: UR-63325

Fluticasone propionate nasal spray

ACTIVE COMPARATOR

Drug: Fluticasone propionate nasal spray

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

UR-63325 DRUG

UR-63325

UR-63325

Fluticasone propionate nasal spray DRUG

Fluticasone propionate nasal spray

Fluticasone propionate nasal spray

Placebo DRUG

Placebo to UR 63325 and fluticasone propionate nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palau Pharma S.L.U.: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rainard Fuhr, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 15, 2011

Record last verified: 2011-04

Locations

DE (1)