Open-label single-arm, multicenter clinical trial to evaluate patient acceptability of a new CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis suffering from pancreatic exocrine insufficiency.

patients with cystic fibrosis suffering from pancreatic exocrine insufficiency

Acceptability of study treatment assessed at Visit 3 (Day 8): • Opening the container • Emptying the dose from container • Taste • Tactile sensation • Color • Time spent taking the dose • General convenience taking the dose • Ease of swallowing • Preparation of final dose to be ingested • Number of dose units to be ingested • Experience of aftertaste after ingestion of treatment • Feeling of fulness after ingestion of the treatment

Lipase dose used per main meal, snack, and over the day, used number of capsules/new formulation., Closing switch questions: o Would you switch your current treatment to the new formulation? o If you would switch to a combination of capsules and new formulation: Under which of the following circumstances, would you use the new formulation? To what extent would you use the new formulation:, Clinical symptoms o Stool frequency per day o Stool consistency (hard, formed, loose) o Abdominal pain on average (none, mild, moderate, severe) o Flatulence on average (none, mild, moderate, severe), Safety and tolerability o Incidence of Adverse events o Incidence of stomatitis/ oral mucosal irritation (investigator) o Inspection of oral cavity /Local tolerability assessment:  Inspection of oral cavity (stomatitis/ oral mucosal irritation, bleeding, ulcera) (by investigator)  Question regarding pain in mouth (subject)

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