Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
An adult or adolescent subject with a diagnosis of persistent asthma of \>=6 months duration may be selected for this study.
Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
Subject must have been using a low daily maintenance dose of inhaled corticosteroids (ICS), with or without added long-acting β2-agonist (LABA), for \>=12 weeks prior to Screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of the predicted value when restricted medications have been withheld.
To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be between 50% and 85% of predicted.
You may not be if
A subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to Screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from Screening to Baseline/Randomization.
In addition, a subject must not have demonstrated a decrease in absolute FEV1 of \>20% at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF) below the PEF stability limit on any 2 consecutive days prior to Baseline/Randomization.
Clareo Health | Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
