A Study to Compare the Efficacy of QAV680 Against Placebo... | NCT00784732

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

NCT00784732

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

44Actual

Phase

Phase 2

Conditions

Seasonal Allergic Rhinitis

Interventions

QAV680
QAV680
Mometasone Furoate

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 3, 2008

First Submission Date that Met QC Criteria

Nov 3, 2008

First Posted Date

Nov 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2016

Last Update Posted Date

Nov 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Label	Type	Intervention Names
1	Experimental	Drug: QAV680
2	Experimental	Drug: QAV680
3	Active Comparator	Drug: Mometasone Furoate

Name	Type	Description	Arm Group Labels	Other Names
QAV680	Drug		1
QAV680	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Novartis Investigator Site	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C588117	NVP-QAV680
D000068656	Mometasone Furoate

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided