Efficacy, Safety, and Pharmacokinetics of QAW039

December 11, 2020 updated by: Novartis Pharmaceuticals

A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma

This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

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

  • Belgium
      • Jambes, Belgium
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Koeln, Germany
        • Novartis Investigative Site
      • Wiesbaden, Germany
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania
        • Novartis Investigative Site
  • United States
    • California
      • Encinitas, California, United States, 92024
        • Novartis Investigative Site
      • Huntington Beach, California, United States, 92647
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90025
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90048
        • Novartis Investigative Site
      • Mission Viejo, California, United States, 92691
        • Novartis Investigative Site
      • San Diego, California, United States, 92123
        • Novartis Investigative Site
      • San Diego, California, United States, 92120
        • Novartis Investigative Site
      • San Jose, California, United States, 95117
        • Novartis Investigative Site
      • Stockton, California, United States, 95207
        • Novartis Investigative Site
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Novartis Investigative Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Novartis Investigative Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Novartis Investigative Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novartis Investigative Site
      • Skillman, New Jersey, United States, 08558
        • Novartis Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Novartis Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novartis Investigative Site
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
        • Novatis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site

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 a medical history of mild to moderate persistent allergic asthma.
  • Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m2.
  • Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

Exclusion Criteria:

  • Women of child-bearing potential.
  • Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
  • Patients with severe persistent 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
QAW039 capsules once daily for 28 days
Drug: QAW039 capsules once daily for 28 days
Experimental: 2
Placebo to QAW039 capsules once daily for 28 days
Drug: Placebo to QAW039 capsules once daily for 28 days
Experimental: 3
Fluticasone propionate inhaler twice daily for 28 days
Drug: Fluticasone propionate inhaler twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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.

General Publications

Helpful Links

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

November 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 1, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAW039A2201
  • 2010-020177-16 (EudraCT Number)

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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