Regele 1996.
Methods | Randomized, double‐blind cross‐over trial without placebo. Duration: 28 days in each arm. Not clear if single center or multicenter, based in Germany. |
Participants | 16 participants (9 females, 7 males) diagnosed with CF by at least 2 sweat chloride values of ≥ 70 mM and pancreatic insufficient. Age: mean 9.9 years, range 3 ‐ 27. |
Interventions | Treatment A: Creon® 25000 (per capsule: 25000 U of lipase, 18000 U of amylase and 1000 U of protease). Treatment B: Panzyrtat (per capsule: 20000 U of lipase, 18000 U of amylase and 1000 U of protease). Both groups received the same number of capsules in each arm. |
Outcomes | FFE, fecal chymotrypsin, fecal immunoreactive human lipase and serum immunoreactive trypsin. |
Notes | Mean FFE for both the arms together was given. FFE for individual treatment periods not given. |