Safety , Pharmacokinetics and efficacy of QAV680 in asthma patients

A randomized, double-blind, two way cross-over, proof of concept study to compare the efficacy, safety, pharmacokinetics and pharmacodynamics of two-week oral administration of QAV680 versus placebo, with an extended open-label inhaled corticosteroid period, in steroid-free, mild to moderate persistent asthma patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000282

Enrollment

Registered

2009-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: QAV680: Experimental Control Intervention1: Matching placebo for QAV680: Placebo comparator Control Intervention2: Fluticasone Propionate: Active comparator

Eligibility

Inclusion criteria

Inclusion criteria: Mild to moderate asthma for at least 6 months.

Exclusion criteria

Exclusion criteria: Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnomalities, abnormal LFT, HIV, Hep B/C, allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatning 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

Design outcomes

Primary

Measure	Time frame
Change in Forced Expiratory Volume in one second (FEV1) as measured by SpirometryTimepoint: two weeks	—

Secondary

Measure	Time frame
Change in Asthma Control Questionnaire (ACQ) scoreTimepoint: Two weeks;Change in exhaled Nitric Oxide (NO)Timepoint: two weeks;Frequency of salbutamol usageTimepoint: 2 weeks;Home monitoring of FEV1 by PIKO monitorsTimepoint: From day 2 to day 13;Pharmacokinetics of multiple doses of QAV680Timepoint: Day1,2, 7 and 14 for the first two periods.	—

Countries

India

Contacts

Public ContactDr. Sureshkumar Kamireddy

Novartis Healthcare Pvt Ltd

suresh_kumar.kamireddy@novartis.com040 67672944

Outcome results