Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma... | NCT00814216

Studies
Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

NCT00814216

Sponsor

Novartis

Status

Completed

Last Update Posted

Mar 8, 2017Actual

Enrollment

37Actual

Phase

Phase 2

Conditions

Asthma

Interventions

QAV680
Matching placebo for QAV680
Fluticasone Propionate

Countries

Germany
India

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

ID	Type	Description	Link
EudraCT number: 2008-005168-15

Status Module

Record Verification Date

Feb 2017

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

Dec 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Not provided

First Submitted Date

Dec 23, 2008

First Submission Date that Met QC Criteria

Dec 23, 2008

First Posted Date

Dec 24, 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

Mar 6, 2017

Last Update Posted Date

Mar 8, 2017Actual

Description Module

Brief Summary

This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'

Detailed Description

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

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
QAV680	Experimental	Drug: QAV680
Placebo	Placebo Comparator	Drug: Matching placebo for QAV680
Fluticasone Propionate Inhaler	Active Comparator	Drug: Fluticasone Propionate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QAV680	Drug		QAV680
Matching placebo for QAV680

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry.		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Measure: Change in Asthma Control Questionnaire (ACQ) score		2 weeks
Measure: Frequency of salbutamol usage		2 weeks
Measure: Change in exhaled Nitric Oxide (NO)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Mild to moderate persistent asthma for at least 6 months.

Exclusion criteria:

Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
Surgical and/or medical conditions which significantly effect ADME of the drug.
Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Berlin			Germany
Novartis Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C588117	NVP-QAV680
D000068298	Fluticasone

Ancestor Terms

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided