A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: QAV680; Drug: Mometasone Furoate

• Registration Number: NCT00784732
• Lead Sponsor: Novartis

Brief Summary

This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Positive skin prick test to ragweed allergen
• FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2.
• Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
• Non-smokers and ex-smokers (≤10 pack years and >6 months of smoking abstinence).
• Understand and sign the written informed consent

Exclusion Criteria

• Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
• Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
• Significant illness within two (2) weeks prior to initial dosing.
• History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	QAV680	-
2	QAV680	-
3	Mometasone Furoate	-

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC	TNSS: 6-8h during EEC exposure on Day 10

Secondary Outcome Measures

Name	Time	Method
Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis	Through out study
Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC	During exposure in EEC
Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)	After 8h exposure in EEC
Total Ocular Symptom Score measured during exposure in the EEC	During exposure in EEC
Absolute eosinophil count from nasal lavage collected	During exposure in EEC

Trial Locations

Locations (1)

Novartis Investigator Site; 🇨🇦 Toronto, Canada