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Dose Finding Study for QAW039 in Asthma

NCT01437735 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1043

Last updated 2020-12-19

No results posted yet for this study

Summary

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

Conditions

Interventions

DRUG

QAW039

QAW039 po

DRUG

Montelukast

Montelukast 10 mg po

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • Argentina
  • Austria
  • Bulgaria
  • Canada
  • Colombia
  • France
  • Greece
  • Guatemala
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Romania
  • Russia
  • South Africa
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437735 on ClinicalTrials.gov