Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

March 6, 2017 updated by: Novartis

Randomized, Double-blind, Two Way Cross-over, Proof of Concept Study to Compare Efficacy, Safety, Pharmacokinetics & Pharmacodynamics of QAV680 Versus Placebo, With an Extended Open-label Corticosteroid Period, in Steroid-free, Mild to Moderate Persistent Asthma Patients.

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.'

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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

  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Munich, Germany
        • Novartis Investigative Site
      • Wiesbaden, Germany
        • Novartis Investigative Site
  • India
      • Ahmedabad, India
        • Novartis Investigative Site
      • Mumbai, India
        • Novartis Investigative Site
      • Mysore, India
        • Novartis Investigative Site
      • Nagpur, India
        • 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:

  • 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

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Matching placebo for QAV680
Experimental: QAV680
Drug: QAV680
Active Comparator: Fluticasone Propionate Inhaler
Drug: Fluticasone Propionate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: Change in Asthma Control Questionnaire (ACQ) score
Time Frame: 2 weeks
2 weeks
Measure: Frequency of salbutamol usage
Time Frame: 2 weeks
2 weeks
Measure: Change in exhaled Nitric Oxide (NO)
Time Frame: 2 weeks
2 weeks
Home Monitoring Of FEV1 By PIKO Monitors
Time Frame: Day 2 to Day 13
Day 2 to Day 13

Collaborators and Investigators

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

Sponsor

Novartis

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.

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

December 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (Estimate)

December 24, 2008

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAV680A2201
  • EudraCT number: 2008-005168-15

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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