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

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Wiesbaden, Germany
        • Novartis Investigative Site
      • Moscow, Russian Federation
        • Novartis Investigative Site
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Research
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QAV680
QAV680 500 mg (5 x 100 mg capsules) four times per day
Placebo Comparator: QAV680 Placebo
Placebo to QAV680 5 capsules four times per day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
FEV1 assessments at various timepoints including time of peak drug concentration
Time Frame: 28 days
28 days
Measure the change in exhaled Nitric Oxide (FeNO)
Time Frame: 28 days
28 days
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
Time Frame: 28 days
28 days
Total serum IgE levels
Time Frame: 28 days
28 days
Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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