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

Seasonal Allergic Rhinitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784732
• Other study ID #: CQAV680A2202
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2008
• Last updated: November 16, 2016
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• QAV680

• QAV680

• Mometasone Furoate

Locations

Country	Name	City	State
Canada	Novartis Investigator Site	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)		After 8h exposure in EEC	Yes
Secondary	Absolute eosinophil count from nasal lavage collected		During exposure in EEC	Yes
Secondary	Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC		During exposure in EEC	No
Secondary	Total Ocular Symptom Score measured during exposure in the EEC		During exposure in EEC	No
Secondary	Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis		Through out study	No

External Links

•   Results for CQAV680A2202 from the Novartis Clinical Trials Website