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NCT00814216 Clinical Trial

Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00814216
Other study ID # CQAV680A2201
Secondary ID EudraCT number:
Status Completed
Phase Phase 2
First received December 23, 2008
Last updated March 6, 2017
Start date December 2008

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.`

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• QAV680

• Matching placebo for QAV680

• Fluticasone Propionate

Locations
Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Munich
Germany Novartis Investigative Site Wiesbaden
India Novartis Investigative Site Ahmedabad
India Novartis Investigative Site Mumbai
India Novartis Investigative Site Mysore
India Novartis Investigative SIte Nagpur

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry. 2 weeks
Secondary Measure: Change in Asthma Control Questionnaire (ACQ) score 2 weeks
Secondary Measure: Frequency of salbutamol usage 2 weeks
Secondary Measure: Change in exhaled Nitric Oxide (NO) 2 weeks
Secondary Home Monitoring Of FEV1 By PIKO Monitors Day 2 to Day 13
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