Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma: Efficacy Assessments
At randomization, current ICS were stopped and the patients were randomized to receive ciclesonide delivered via HFA-MDI at 640 |j,g/d (CIC640; 80 ^g X four puffs bid); ciclesonide delivered via HFA-MDI at 1,280 |xg/d (CIC1280; 160 |xg X four puffs bid); or placebo (all received at 8 am and 8 pm). During each of the 12 weekly follow-up visits, patients were evaluated to determine their eligibility for prednisone dose reduction based on the criteria described in Table 2. Doses were adjusted according to the dosing steps described in Tables 3, 4. Link
The protocol was approved by an independent ethics review committee and institutional review boards, and the study was conducted in accordance with the principles of good clinical practice, as outlined in the Declaration of Helsinki. Informed consent was obtained from patients prior to the conduct of any study-related procedures. All assessments were performed at the weekly clinic visits. The primary efficacy measure was the percentage change from baseline to week 12 in prednisone dose. Additional outcome measures included the percentage of patients reducing or discontinuing prednisone use, within specific ranges; changes from baseline in FEV1 and patient-measured morning peak expiratory flow (PEF); the time to study discontinuation due to a lack of efficacy or an asthma-aggravated AE; and the change from baseline in 24-h symptom scores and daily albuterol use.
Patients were instructed to use daily diary cards to record prednisone use, concomitant medications, PEF, 24-h asthma symptom rating score, and albuterol use (puffs per day). The asthma symptom scores were based on a 5-point asthma symptom score over 24 h and defined as the sum of the daytime and nighttime asthma symptom scores. These were assessed twice daily (prior to measuring PEF) by the patient, using the following criteria: 0 = no symptoms; 1 = occasional wheezing, cough, or shortness of breath but no interference with daily activities or sleep; 2 = occasional wheezing, cough, or shortness of breath, with interference of daily activities or sleep; 3 = frequent or continuous wheezing, cough, or shortness of breath, with interference of daily activities or sleep; 4 = symptoms that prevent the patient from engaging in daily activities or sleep.