The trial was conducted between July 2001 and March 2003. Overall, 241 patients were screened, and 141 patients (80 in the United States and 61 in South Africa) were randomized to receive treatment at 60 sites within these countries (CIC640, n = 47; CIC1280, n = 49; placebo, n = 45). Patient disposition throughout the […]
The investigators assessed patients for AEs; in addition, patients reported AEs in their patient diaries. Data from physical examinations and clinical laboratory tests were collected at screening and week 12. HPA-axis function was assessed at randomization and at week 12 via cosyntropin stimulation. Blood samples for serum cortisol measurements were collected before and after stimulation […]
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 […]
Prior to randomization, during the screening period, the lowest effective dose of oral prednisone was established for each patient. This was determined in one of two ways: (1) a documented history verifying failed attempts at prednisone dose reduction within 2 months prior to screening/baseline; such patients were considered to be currently on their lowest effective […]
Taken together, these data suggest that ciclesonide, with its favorable therapeutic profile, may be a suitable OCS-sparing therapy. We report here the results of a placebo-controlled study examining the efficacy of ciclesonide administered twice daily in reducing the use of the OCS prednisone in patients with severe, persistent asthma. The effects on HPA-axis function and […]
Inhaled corticosteroids (ICS) are the most effective agents for controlling persistent asthma. However, in very severe cases and during exacerbations, oral corticosteroids (OCS) are necessary. As systemic adverse events (AEs) are associated with OCS use, oral steroid-sparing strategies are employed and have been demonstrated with ICS such as be-clomethasone dipropionate, budesonide, and fluticasone propionate in […]
The marked delay in onset of symptoms may also be explained by the lesser degree of mediastinal shift (Fig 2). Dynamic bronchoscopy revealed severe reduction in the airway lumen due to diffuse collapse of the anterior cartilaginous structures consistent with crescent type of tracheobronchomalacia (Fig 3) extending throughout the lower trachea, right main bronchus, and […]