Role of Roflumilast in Ulcerative Colitis

• Study design and study population This study will be randomized, controlled, parallel study.
• It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups

• Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months.
• Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
• Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.
• A written informed consent will be obtained from all patients
• This study will be approved by the Research Ethics Committee of Tanta University.
• Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form .
• Randomization will be carried out based on days of hospital admission

Inclusion criteria

• Patients referred to endoscopy units in Tanta University hospitals during the period of the study.

Patient with mild to moderate UC diagnosed as:

• Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss.
• Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.

Exclusion criteria

• Other inflammatory bowel disease (crohn's disease) .
• Patients <15 and >80 years
• Patients who didn't give consent to participate in the study
• Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded
• History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness .
• Depression , thoughts of suicide , anxiety and emotional instability .
• Excessive weight loss .
• Moderate to severe hepatic impairment (child pugh class B or C) .
• Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction )
• Loxapine ( Risk , X interaction )