Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a randomized, double blind, placebo-controlled, parallel group study and will include subjects with ragweed-induced seasonal allergic rhinitis.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Creighton University
• Collaborator: Roche Pharma AG
• Treatments: Fluticasone; Montelukast

Criteria

Inclusion Criteria:

• Male or female subjects aged 19-60 years.

• Females of child bearing potential must use appropriate birth control throughout the study and urine pregnancy tests must be negative prior to dosing at each study visit.

• Subjects with a documented history of ragweed-induced seasonal allergic rhinitis requiring pharmacotherapy during the preceding 2 allergen seasons.

• Subjects with a positive skin prick test to short ragweed (Amb a 1) extract, defined as >3mm wheal larger than saline control

• Subjects spirometry FEV1 must be > 80% predicted prior to each allergen challenge

• Subjects average post diluents nasal congestion score must be < 1 at admission for each study visit

Exclusion Criteria:

• Subjects with evidence or history of clinically significant medical illnesses other than changes related to allergic rhinitis. Subjects with some stable chronic medical conditions not expected to interfere with the conduct or safety of the study may be eligible to participate based on the investigator's discretion.

• Subjects with a history of asthma or urticaria, or a screening FEV1 prior to allergen challenge of <80% of predicted. in FEV1 compared to pre-diluent FEV1 baseline at either screening visit.

• Subjects with significant nasal deformity, recent nasal surgery nasal polyps or chronic rhinosinusitis.

• Subjects who have smoked in the last 6 months or have a history of >10 pack years.

• Subjects who are taking or have taken restricted concomitant medications that could confound the safety or efficacy assessments including those shown below.

• Subjects who have history or evidence of alcohol or drug abuse.

• Subjects exposed to cat and have a positive skin test to cat.

• Subjects that have a positive skin test to dust mite (D pteronyssinus/ D farinae) requiring pharmacotherapy