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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QAV680
QAV680 Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Mild, Moderate, Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Coast Clinical Trials
  • American Health Research
  • North Carolina Clinical Research
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QAV680

QAV680 Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry

Secondary Outcome Measures

FEV1 assessments at various timepoints including time of peak drug concentration
Measure the change in exhaled Nitric Oxide (FeNO)
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
Total serum IgE levels
Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.

Full Information

First Posted
April 12, 2010
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01103037
Brief Title
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma
Official Title
A Randomized, Double-blind, Parallel Group Study to Compare the Pharmacodynamics/Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Moderate Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated by sponsor
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Mild, Moderate, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QAV680
Arm Type
Experimental
Arm Title
QAV680 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
QAV680
Intervention Description
QAV680 500 mg (5 x 100 mg capsules) four times per day
Intervention Type
Drug
Intervention Name(s)
QAV680 Placebo
Intervention Description
Placebo to QAV680 5 capsules four times per day
Primary Outcome Measure Information:
Title
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
Time Frame
28 days
Secondary Outcome Measure Information:
Title
FEV1 assessments at various timepoints including time of peak drug concentration
Time Frame
28 days
Title
Measure the change in exhaled Nitric Oxide (FeNO)
Time Frame
28 days
Title
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
Time Frame
28 days
Title
Total serum IgE levels
Time Frame
28 days
Title
Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
West Coast Clinical Trials
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
Country
Germany
Facility Name
Novartis Investigative Site
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6683
Description
Results for CQAV680A2201E1 from the Novartis Clinical Trials website

Learn more about this trial

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

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