Clinical Trials Logo
  1. Home
  2. Asthma
  3. NCT01130064
  4. Details
NCT01130064 Clinical Trial

Efficacy of QAX576 in Asthma

Asthma Clinical Trial

Official title:
A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01130064
Other study ID # CQAX576A2207
Secondary ID 2009-011590-32
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2010
Est. completion date April 2012

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.

Recruitment information / eligibility
Status Completed
Enrollment 259
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male and female patients - Female patients must be surgically sterilized or postmenopausal - Male patients must use two forms of contraception - Body mass index must be between 18 and 39 kg/m2 - Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists Exclusion Criteria: - Smoking history >10 pack-years - Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) - Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening - Patients who have had a respiratory tract infection within 6 weeks prior to screening - History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• QAX576
every 3 weeks via intravenous infusion
Drug:
• Placebo
every 3 weeks via intravenous infusion

Locations
Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Mendoza
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Santa Fe
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Eupen
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Laeken
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Liège
Czechia Novartis Investigative Site Rokycany Czech Republic
Czechia Novartis Investigative Site Strakonice Czech Republic
Czechia Novartis Investigative Site Tabor
Czechia Novartis Investigative Site Teplice CZE
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Grosshansdorf
Germany Novartis Investigative Site Kassel
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Mainz
Germany Novartis Investigative Site Rüdersdorf
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Lodz
Poland Novartis Investigative Site Lublin
Poland Novartis Investigative Site Poznan
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Kazan Tatarstan Republic
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Nizhny Novgorod
Russian Federation Novartis Investigative Site Ryazan
Russian Federation Novartis Investigative Site Samara
Russian Federation Novartis Investigative Site Yaroslavl
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Huntington Beach California
United States Novartis Investigative Site Las Vegas Nevada
United States Novartis Investigative Site Marion Ohio
United States Novartis Investigative Site Minneapolis Minnesota
United States Novartis Investigative Site Owensboro Kentucky
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site Summerville South Carolina
United States Novartis Investigative Site Wheaton Maryland

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Czechia,  Germany,  Poland,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Asthma Control Questionnaire 24 weeks
Secondary Incidence rate of clinically significant asthma exacerbations 24 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

External Links