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

NCT00784732 | Completed Phase 2

• 1 other identifier: CQAV680A2202
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal Allergic Rhinitis; Environmental Exposure Chamber; nasal lavage

Outcome Measures

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

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

Secondary Outcomes (5)

• 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

Study Arms (3)

1

EXPERIMENTAL

Drug: QAV680

2

EXPERIMENTAL

Drug: QAV680

3

ACTIVE COMPARATOR

Drug: Mometasone Furoate

Interventions

QAV680 DRUG

1

Mometasone Furoate DRUG

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigator Site

Toronto, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

NVP-QAV680; Mometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Novartis

  Novartis Investigator Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 4, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

CA (1)