Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
4–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
History of persistent bronchial asthma for at least 3 months prior to screening;
For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
Only patients aged between 6 to \<12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol
You may not be if
Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
History of life-threatening asthma, including a history of significant hypercarbia (pCO2 \>45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
Clareo Health | Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
