A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Se... | Completed
A Study to Establish the Efficacy o... | Completed
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.

Medical Conditions
  • Asthma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01479595
Primary Trial ID Number
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Gender
Both
Age Range
18 Years - 65 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Trial Location(s)
Novartis Investigative Site
London
SE11YR
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Germany, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
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

Jan 2012

Recruitment End Date

Feb 2015

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

22 Nov 2011

Last Updated

08 Jan 2016

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