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

A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00784732

Enrollment

Registered

2008-11-04

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal Allergic Rhinitis, Environmental Exposure Chamber, nasal lavage

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.

Interventions

DRUGQAV680

DRUGMometasone Furoate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026