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Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

QAV680

Matching placebo for QAV680

Fluticasone Propionate

About this trial

This is an interventional treatment trial for Asthma focused on measuring Efficacy, safety, QAV680, pharmacokinetics, corticosteroid, asthma

Eligibility Criteria

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

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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative SIte

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

QAV680

Placebo

Fluticasone Propionate Inhaler

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measure: Change in Asthma Control Questionnaire (ACQ) score

Measure: Frequency of salbutamol usage

Measure: Change in exhaled Nitric Oxide (NO)

Home Monitoring Of FEV1 By PIKO Monitors

Full Information

NCT ID

NCT00814216

First Posted

December 23, 2008

Last Updated

March 6, 2017

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00814216

Brief Title

Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

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.'

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Efficacy, safety, QAV680, pharmacokinetics, corticosteroid, asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QAV680

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Fluticasone Propionate Inhaler

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

QAV680

Intervention Type

Drug

Intervention Name(s)

Matching placebo for QAV680

Intervention Type

Drug

Intervention Name(s)

Fluticasone Propionate

Primary Outcome Measure Information:

Title

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

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Measure: Change in Asthma Control Questionnaire (ACQ) score

Time Frame

2 weeks

Title

Measure: Frequency of salbutamol usage

Time Frame

2 weeks

Title

Measure: Change in exhaled Nitric Oxide (NO)

Time Frame

2 weeks

Title

Home Monitoring Of FEV1 By PIKO Monitors

Time Frame

Day 2 to Day 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

Novartis Investigative Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Munich

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

Country

Germany

Facility Name

Novartis Investigative Site

City

Ahmedabad

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

Country

India

Facility Name

Novartis Investigative SIte

City

Nagpur

Country

India

12. IPD Sharing Statement

Links:

URL

http://erj.ersjournals.com/content/44/Suppl_58/P4071

Description

Results for CQAV680A2201 from the European Respiratory Journal (ERJ)

Learn more about this trial

Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

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