A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma | Recruiting
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Asthma
Novartis Pharmaceuticals
1-888-669-6682
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01479595
Primary Trial ID Number
Summary
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : QBX258, Drug : Placebo

Study Arm Groups : QBX258 - Active, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Change in Asthma Control Questionnaire score; Baseline and 12 weeks
Secondary Outcome Measures
  • Change in Forced Expiratory Volume in one second (FEV1); Baseline and 26 weeks; Change in Asthma Quality of Life Questionnaire score; Baseline and 12 weeks; Morning and evening peak expiratory flow rate; Baseline and 26 weeks
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 65 Years
Who Can Participate
Patients
Number of Participants
60
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Patients with atopic asthma >1 year duration diagnosed according to the GINA
  • guidelines.
  • - Subjects must weigh at least 50 kg to participate in the study, and must have a body
  • mass index (BMI) within the range of 18 - 39 kg/m2.
  • - Asthma which is not adequately controlled on current treatment, as demonstrated by an
  • Asthma Control Questionnaire (ACQ) score of > 1.5.
  • - FEV1 40 to 90% of predicted.
  • Exclusion Criteria:
  • - Diagnosed with COPD as defined by the GOLD guidelines
  • - Subjects who have had a respiratory tract infection within 4 weeks prior to
  • screening.
  • - Women of child-bearing potential must use highly effective methods of contraception
  • during dosing and for at least 18 weeks after last study drug administration
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
National Heart and Lung Institute
London
England
W2 1PG
London Chest Hospital
London
E2 9JX
Medicines Evaluation Unit Ltd (MEU)
Manchester
M23 9QZ
Novartis Investigative Site
London
SW3 6PH
Pfizer Investigational Site
Belfast
Northern Ireland
BT9 6AD
Novartis Investigative Site
London
SE11YR
Trial Contact(s)
Primary Trial Contact
Novartis Pharmaceuticals
1-888-669-6682
Other Trial Contacts
Novartis Pharmaceuticals
Countries Recruiting
United States, Germany, United Kingdom
Scientific Title
A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CQBX258X2201
Sponsor(s)
Novartis Pharmaceuticals
Key Dates

Recruitment Start Date

Feb 2012

Recruitment End Date

Apr 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

22 Nov 2011

Last Updated

03 Nov 2014