asthma chronic lung inflammation
Conditions
Interventions
The study will consist of a
14-day screening period, followed by a 14-day run-in period, and a treatment
epoch which consists of three treatment periods, with a minimum duration of
14 days each follow
Randomized
repeat-dose
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria: * patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose * on a stable regimen for at least 4 weeks prior to screening. * Pre-bronchodilator FEV1 * 60 % and
Exclusion criteria
Exclusion criteria: * Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class * Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening. * Patients who have had previous intubation for a severe asthma attack/exacerbation. * Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers. * History of paradoxical bronchospasm in response to inhaled medicines. * Patients who during the run-in period prior to randomization require the use of *12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEF of * 30% for 6 consecutive scheduled PEF readings * Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the potential influence of time of dosing (morning or evening) on the bronchodilator effect of once daily orally inhaled QVM149 compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To investigate the potential influence of time of dosing (morning or evening) on trough FEV1 of once daily orally inhaled QVM149 compared to placebo. * To investigate the potential influence of time of dosing (morning or evening), on peak expiratory flow rate (PEF) of once daily orally inhaled QVM149 compared to placebo. * To evaluate safety and tolerability of QVM149 when dosed in the morning or in the evening in patients with asthma after during two weeks of treatment in each treatment period. | — |
Countries
The Netherlands
Outcome results
None listed