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CompletedNCT00784732Updated Nov 18, 2016

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

A Phase 2 interventional study of QAV680 and QAV680 in Seasonal Allergic Rhinitis, sponsored by Novartis. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Seasonal Allergic Rhinitis

Keywords

  • Seasonal Allergic Rhinitis
  • Environmental Exposure Chamber
  • nasal lavage
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 44 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    1

    Drug: QAV680

  • Experimental
    2

    Drug: QAV680

  • Active comparator
    3

    Drug: Mometasone Furoate

Interventions

  • DrugQAV680
  • DrugQAV680
  • DrugMometasone Furoate
06

What researchers measure

Primary outcomes

  1. Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC

    Time frame: TNSS: 6-8h during EEC exposure on Day 10

Secondary outcomes

  1. Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)

    Time frame: After 8h exposure in EEC

  2. Absolute eosinophil count from nasal lavage collected

    Time frame: During exposure in EEC

  3. Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC

    Time frame: During exposure in EEC

  4. Total Ocular Symptom Score measured during exposure in the EEC

    Time frame: During exposure in EEC

  5. Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis

    Time frame: Through out study

07

Study locations

1 site
  • Novartis Investigator Site
    Toronto, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00784732
Lead sponsor
Novartis
First posted
Nov 4, 2008
Start date
Sep 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Nov 18, 2016

Study contacts

Novartis
principal investigator · Novartis Investigator Site

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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