Asthma
Conditions
Keywords
Efficacy, safety, QAV680, pharmacokinetics, corticosteroid, asthma
Brief summary
This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate persistent asthma for at least 6 months.
Exclusion criteria
* Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C, * Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc * Surgical and/or medical conditions which significantly effect ADME of the drug. * Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry. | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Change in Asthma Control Questionnaire (ACQ) score | 2 weeks |
| Measure: Frequency of salbutamol usage | 2 weeks |
| Measure: Change in exhaled Nitric Oxide (NO) | 2 weeks |
| Home Monitoring Of FEV1 By PIKO Monitors | Day 2 to Day 13 |
Countries
Germany, India
Outcome results
None listed