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OpenTrials
Completed

NCT Number: NCT00814216

Efficacy, Safety and Pharmacokinetics of QAV680 in 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.'

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QAV680

Drug

Matching placebo for QAV680

Drug

Fluticasone propionate

Drug

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

  1. Measure: Change in Asthma Control Questionnaire (ACQ) score

    Time frame: 2 weeks

  2. Measure: Frequency of salbutamol usage

    Time frame: 2 weeks

  3. Measure: Change in exhaled Nitric Oxide (NO)

    Time frame: 2 weeks

  4. Home Monitoring Of FEV1 By PIKO Monitors

    Time frame: Day 2 to Day 13

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
First posted
Dec 24, 2008
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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