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

This study has been completed.
Sponsor:
Information provided by:
Palau Pharma S.A.
ClinicalTrials.gov Identifier:
NCT01260753
First received: December 13, 2010
Last updated: April 14, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: UR-63325
Drug: Fluticasone propionate nasal spray
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Palau Pharma S.A.:

Primary Outcome Measures:
  • Nasal and ocular symptoms scores after nasal allergen challenge [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory parameters measured from nasal exudate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UR-63325 Drug: UR-63325
UR-63325
Active Comparator: Fluticasone propionate nasal spray Drug: Fluticasone propionate nasal spray
Fluticasone propionate nasal spray
Placebo Comparator: Placebo Drug: Placebo
Placebo to UR 63325 and fluticasone propionate nasal spray

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260753

Locations
Germany
Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Palau Pharma S.A.
Investigators
Principal Investigator: Rainard Fuhr, MD Parexel International GmbH
  More Information

No publications provided

Responsible Party: Roser Vives MD, Clinical Research Scientist, Palau Pharma S.A.
ClinicalTrials.gov Identifier: NCT01260753     History of Changes
Other Study ID Numbers: PPh/00071/10, 2010-021858-20
Study First Received: December 13, 2010
Last Updated: April 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013