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Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00814216
First received: December 23, 2008
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  Purpose

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.`


Condition Intervention Phase
Asthma
 Drug: QAV680
Drug: Matching placebo for QAV680
Drug: Fluticasone Propionate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: Change in Asthma Control Questionnaire (ACQ) score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Measure: Frequency of salbutamol usage [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Measure: Change in exhaled Nitric Oxide (NO) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Home Monitoring Of FEV1 By PIKO Monitors [ Time Frame: Day 2 to Day 13 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QAV680 Drug: QAV680
Placebo Comparator: Placebo Drug: Matching placebo for QAV680
Active Comparator: Fluticasone Propionate Inhaler Drug: Fluticasone Propionate

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814216

Locations
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Munich, Germany
Novartis Investigative Site
Wiesbaden, Germany
India
Novartis Investigative Site
Ahmedabad, India
Novartis Investigative Site
Mumbai, India
Novartis Investigative Site
Mysore, India
Novartis Investigative SIte
Nagpur, India
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00814216     History of Changes
Other Study ID Numbers: CQAV680A2201, EudraCT number: 2008-005168-15
Study First Received: December 23, 2008
Last Updated: September 22, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India

Keywords provided by Novartis:
Efficacy
safety
QAV680
 pharmacokinetics
corticosteroid
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013