Safety of Fentanyl TAIFUN Treatment

Inclusion Criteria:

• Age 18 Years or older

• A medically documented diagnosis of cancer

• Use of a fixed round the clock dose of opioid as maintenance therapy with a doseequivalence of at least 60mg of oral morphine/ day, or at least 25 mcg of transdermalfentanyl/ hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oralhydromorphone daily. Current opioid treatment for at least 7 days prior torandomization

• Current use of opioid medication for BTP

• At least 4 episodes of BTP per week, with peak intensity of at least 4 on the NPS atpain onset. No more than 4 BTP episodes per day.

• PIFR of at least 20L/min

• Karofsky Performance Status of 40 or better

• Life expectancy of at least 12 weeks

• Written Informed Consent

Exclusion Criteria:

• Uncontrolled or rapidly increasing BTP

• Symptomatic intracranial tumors or cerebral metastases

• Persistent symptomatic asthma

• Patients unable to use the inhaler

• Inadequate lung function, as defined by PEFR <60%

• Hypersensitivities, allergies or contraindications to fentanyl or the study medicationcomponents

• A recent history of alcohol or substance abuse (in the past 1 year)

• Radiotherapy to the thorax within 30 days of the beginning of the titration phase

• Cognitive impairment or any neurological of psychiatric disease which could compromisethe ability of the patient to complete the assessments

• Participation in any clinical study with an experimental drug within 30 days ofrandomization

• Any clinical condition or medical history which, in the opinion of the investigatorwould not allow for the safe completion of the study or the safe administration of thestudy drug

• Pre-menopausal women who are not surgically sterile and/or have a positive pregnancytest at baseline visit and/ or are of child bearing potential and are not using areliable method of birth control or do not plan to continue using this methodthroughout the study and/or who are nursing