Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: QAV680; Drug: Matching placebo for QAV680; Drug: Fluticasone Propionate

• Registration Number: NCT00814216
• Lead Sponsor: Novartis

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.'

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-23
• Study First Posted: 2008-12-24
• Primary Completion: 2009-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
QAV680	QAV680	-
Placebo	Matching placebo for QAV680	-
Fluticasone Propionate Inhaler	Fluticasone Propionate	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Novartis Investigative Site; 🇮🇳 Mysore, India

Novartis Investigative SIte; 🇮🇳 Nagpur, India