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Completed

NCT Number: NCT01253603

Efficacy, Safety, and Pharmacokinetics of QAW039

This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

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Key information

Conditions

Persistent Asthma 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, Jambes, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a medical history of mild to moderate persistent allergic asthma.
  • Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m2.
  • Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

Exclusion criteria

  • Women of child-bearing potential.
  • Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
  • Patients with severe persistent asthma

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

QAW039 capsules once daily for 28 days

Drug

Placebo to QAW039 capsules once daily for 28 days

Drug

Fluticasone propionate inhaler twice daily for 28 days

Drug

Primary outcomes

  1. Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.

    Time frame: 28 days

Secondary outcomes

  1. To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 3, 2010
Registry last updated
Dec 19, 2020

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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