Efficacy, Safety and Pharmacokinetics of QAV680 Versus Pl... | NCT01103037

Studies
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma

NCT01103037

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Dec 19, 2020Actual

Enrollment

8Actual

Phase

Phase 2

Conditions

Asthma

Interventions

QAV680
QAV680 Placebo

Countries

United States
Germany
Russia

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
2009-017267-41	EudraCT Number

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated by sponsor

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Apr 12, 2010

First Submission Date that Met QC Criteria

Apr 12, 2010

First Posted Date

Apr 13, 2010Estimated

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

May 2, 2012

Certification/Extension First Submitted that Passed QC Review

May 2, 2012

Certification/Extension First Posted Date

May 4, 2012Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 19, 2020Actual

Description Module

Brief Summary

This study will assess the safety and efficacy of QAV680 in patients with mild to moderate 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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QAV680	Experimental		Drug: QAV680
QAV680 Placebo	Placebo Comparator		Drug: QAV680 Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QAV680	Drug	QAV680 500 mg (5 x 100 mg capsules) four times per day	QAV680

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry		28 days

Secondary Outcomes

Measure	Description	Time Frame
FEV1 assessments at various timepoints including time of peak drug concentration		28 days
Measure the change in exhaled Nitric Oxide (FeNO)		28 days
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with moderate persistent asthma

Exclusion Criteria:

Smokers
Any significant disease or illness, other than asthma

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
West Coast Clinical Trials		Cypress	California	90630	United States
American Health Research

References Module

Citations

Not provided

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

ID	Term
D001249	Asthma
D008224	Lymphoma, Follicular