A study to establish the efficacy of QBX258 in patients with moderate to severe asthma.
- Conditions
- Patients with asthma that are inadequately controlled with inhaled corticosteroids and long acting beta agonistsMedDRA version: 17.0 Level: LLT Classification code 10049106 Term: Asthma chronic System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-003066-32-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
* 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.
Other inclusion criteria are listed in the clinical study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
* Diagnosed with COPD as defined by the GOLD guidelines
* Subjects who have had a respiratory tract infection within 4 weeks prior to screening.Patients should not have symptoms of an active respiratory tract infection at the time of
randomization.
* 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
Other inclusion criteria are listed in the clinical study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method