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Topical Allstate and Nasal Allergen Challenge

This study has been withdrawn prior to enrollment.
(study halted prematurely, prior to enrollment of first participant)
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT01231724
First received: October 28, 2010
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).


Condition Intervention Phase
Allergic Rhinitis
 Device: Allstate Nasal Spray
Device: Placebo Nasal Spray
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints. [ Time Frame: 10 minutes following each nasal challenge ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allstate Nasal Spray Device: Allstate Nasal Spray
Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.
Placebo Comparator: Placebo Nasal Spray Device: Placebo Nasal Spray
2 sprays in each nostril

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Males and females between 18 and 55 years of age.
  2. History of grass and/or ragweed allergic rhinitis for at least 2 years.
  3. Positive skin test to grass and/or ragweed antigen within prior 12 months.
  4. Positive response to screening nasal challenge.

Exclusion Criteria

  1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
  2. Use of nasal steroids, antihistamines in the last 2 weeks.
  3. Upper respiratory infection, sinusitis less than 2 weeks before screening.
  4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
  5. Having poorly tolerated previous administration of allergens
  6. Nasolacrimal drainage system malfunctions.
  7. Participation in other investigational therapy in the last 30 days.
  8. Any systemic disorder or medication interfering with the study.
  9. FEV1<80% of predicted at screening for subjects with mild asthma.
  10. Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline)
  11. Undergoing allergen desensitization therapy.
  12. Current smokers or recent ex-smokers.
  13. Not willing to give informed consent
  14. Inability to understand the nature and requirements of the study, or to comply with the study procedures.
  15. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231724

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

No publications provided

Responsible Party: Robert Naclerio, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01231724     History of Changes
Other Study ID Numbers: 10-224-A
Study First Received: October 28, 2010
Last Updated: September 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013