Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)
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
5–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines
Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks
Is able to demonstrate an FEV1 \>60% and ≤90% predicted
Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.
Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.
Is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.
Has laboratory tests that are clinically acceptable to the investigator.
You may not be if
Requires \>8 inhalations per day of albuterol (100 mcg per actuation), and/or \>2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days
Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.
Is considered by the investigator to have unstable asthma at the end of the run-in period
Has had \> 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1
Has had a history of life-threatening asthma
Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial
Clareo Health | Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)
