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Completed

NCT Number: NCT00784732

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigator Site

Toronto, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QAV680

Drug

Mometasone furoate

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 4, 2008
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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