title: Oral prolonged release beclomethasone dipropionate and prednisone in the treatment of active ulcerative colitis: results from a double-blind, randomized, parallel group study.
abstract: OBJECTIVE
  Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC).
  
  
  METHODS
  Overall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4.
  
  
  RESULTS
  DAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: -1.56; 95% confidence interval (CI) -13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups.
  
  
  CONCLUSIONS
  BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.
authors: Department of Gastroenterology, UZ Gasthuisberg, Leuven, Belgium.
authors: Gert
authors: G
authors: Van Assche
authors: Division of Gastroenterology and Endoscopy, Cardarelli Hospital, Naples, Italy.
authors: Francesco
authors: F
authors: Manguso
authors: Corporate Clinical Development, Chiesi Farmaceutici S.p.A., Parma, Italy.
authors: Marco
authors: M
authors: Zibellini
authors: Hospital Galdakao, Barrio Labeaga, Vizcaya, Spain.
authors: José Luis
authors: JL
authors: Cabriada Nuño
authors: Policlinica Algomed, Centru Medical e Gastroenterologie, Medicina Interna si Nefrologie, Timisoara, Romania.
authors: Adrian
authors: A
authors: Goldis
authors: St Petersburg State Medical Academy n.a. I.I. Mechnikov, St Petersburg, Russia.
authors: Evgeniy
authors: E
authors: Tkachenko
authors: Corporate Clinical Development, Chiesi Farmaceutici S.p.A., Parma, Italy.
authors: Guido
authors: G
authors: Varoli
authors: Endoskopia B. Chrobrego 6/8 81-756, Sopot, Poland.
authors: Dariusz
authors: D
authors: Kleczkowski
authors: Department of Gastroenterology, University Hospital Careggi, Florence, Italy.
authors: Vito
authors: V
authors: Annese
authors: Department of Gastroenterology and Hepatology, AZ Groeninge, Kortrijk, Belgium.
authors: François
authors: F
authors: D'Heygere
authors: Division of Gastroenterology and Endoscopy, Cardarelli Hospital, Naples, Italy.
authors: Antonio
authors: A
authors: Balzano
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013608:Tablets, Enteric-Coated; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D013608:Tablets, Enteric-Coated; D001507:Beclomethasone; D011241:Prednisone; D006854:Hydrocortisone