Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 \< 100% of the predicted normal value for the patient during screening.
Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening.
At screening, and baseline (day 1 pre-dose time) of the first treatment period, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position as outlined in the SOM. Sitting and standing vital signs should be within the following ranges:
oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-159 mmHg
diastolic blood pressure, 50-99 mmHg
pulse rate, 40-90 bpm
Hypertensive patients must have been on stable antihypertensive therapy for at least 4 weeks prior to screening to be included in the trial.
Patients must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.
You may not be if
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 ttack/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 PEFof ≥ 30% for 6 consecutive scheduled PEF readings
Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).
Clareo Health | Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma
