None listed
Conditions
Brief summary
This study aims to examine the effect of fentanyl applied intra-nasally for the management of shortness of breath in patients with advanced non- malignant disease when their symptoms have become less responsive to treatment of the underlying disease. Intranasal fentanyl is already widely used for the treatment of pain in clinical practice and therefore their side effects are well known. The dosage used in this study is much lower than what is normally used for pain, therefore the risk of adverse events is expected to be lower than expected. Eligible patients enrolled in the hospice programme are invited to participate.
Interventions
Participants are to be randomized into 2 treatment groups with sequences composed of 2 sets of 3 administrations (number 1-3 and 4-6), with each set comprising of fentanyl 5 microgram/puff, and placebo- an inactive drug. Patients in group 1 receive fentanyl in bottles 1-3 and placebo in bottles 4-6. Patients in group 2 receive placebo in bottles 1-3 and fentanyl in bottles 4-6. Patients are instructed to treat 6 episodes of acute shortness of breath using the order the spray bottles are ordered
Participants are to be randomized into 2 treatment groups with sequences composed of 2 sets of 3 administrations (number 1-3 and 4-6), with each set comprising of fentanyl 5 microgram/puff, and placebo- an inactive drug. Patients in group 1 receive fentanyl in bottles 1-3 and placebo in bottles 4-6. Patients in group 2 receive placebo in bottles 1-3 and fentanyl in bottles 4-6. Patients are instructed to treat 6 episodes of acute shortness of breath using the order the spray bottles are ordered and they are to record their response at set interval. If symptom persists after 15 minutes, they are to take their usual rescue medication. Results are then analyzed to determine efficacy and any adverse effects of the treatment. Intra-nasal fentanyl, 5mcg/puff, 2 puffs are administered into each nostril = total dose of 20mcg for each breathlessness episode. This can be repeated upto hourly. The number of episodes to be treated is six episodes per patient. This is based on pharmacokinetic study that shows therapeutic concentration is achieved within 2 minutes and elimination half -lives are found to be 29.8 and 31.2 minutes for solution pH of 6 and 8 respectively. (Lim, Sunderland et al 2003). Based on the above mentioned half-lives, the wash out period between fentanyl and placebo is 60 minutes. Adherence is based on what is reported by patients using study questionnaires that record study drug use. The questionnaires are collected and checked with patients at the final study visit. it is expected six breathlessness episodes are very readily achievable over 24 hours to 7 day period in hospice patients who have high symptom burden. Lim S, Paech MJ, Sunderland B, Roberts MJ, Banks SL, Matthew R. Pharmacokinetics of Nasal Fentanyl. Journal of Pharmacy Practice and Research. 2003;33(1):59-63
Sponsors
Medical Director, Dr Ian Gwynne Robson
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study population is composed of enrolled hospice patients with the following eligibility criteria: Age, 18 and above Primary diagnosis of non-malignant disease Symptom of episodic dyspnoea on a daily basis at least once per day in the previous week already on rescue opioid for episodic dypsnea
Exclusion criteria
Diagnosis of malignancy Non English speaking Unable to give informed consent confirmed or suspected pregnancy history of current history of depression
Outcome results
None listed