Status:
UNKNOWN
Morphine for Dyspnea in Pulmonary Fibrosis
Lead Sponsor:
Medical University of Gdansk
Conditions:
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
"Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"
Eligibility Criteria
Inclusion
- IPF diagnosis in accordance with guidelines
- Period of stable disease
- Dyspnea rated 3 to 4 in mMRC scale
- Current non-smoker
- Other potential causes of breathlessness such as kidney or heart failure optimally treated in the opinion of the principal investigator
- Able to complete questionnaires and trial assessments
- Ability to give informed consent
- If female, must be:
- postmenopausal (no menses for 12 months without an alternative medical cause)
- sterile
- using acceptable contraception and agree to exclude pregnancy with pregnancy test in the beginning of the hospitalization
Exclusion
- \- other coexisting severe chronic lung diseases
- absolute contraindications to six-minute-walking-test according to
- Polish Respiratory Society guidelines:
- \< 7-10 days since coronary interventions due to STEMI
- \< 24 h since planned coronary intervention
- myocarditis/pericarditis
- symptomatic rhythm and conduction abnormalities
- acute deep vein thrombosis, pulmonary embolism, pulmonary infarction
- decompensated heart failure
- acute infection and other diseases which can significantly impact the test result (eg. severe anemia, acute kidney or liver failure, hypo- or hyperthyroidism, etc)
- \- contraindications to morphine hydrochloride:
- previous history of respiratory depression after opioid administration
- previous history of allergic reactions to opioids
- severe ventilation impairment due to e.g. asthmatic state, airway foreign body
- severe kidney or liver failure
- increased intracranial pressure
- head injury
- cerebral edema
- coma
- seizure disorders
- acute alcohol poisoning
- acute abdomen
- acute diarrhea caused by infection or food poisoning;
- patients at risk of paralytic ileus;
- biliary colic;
- phaeochromocytoma;
- simultaneous MAO inhibitor treatment and immediate 2-week period following its discontinuation - ongoing opioid treatment for any indication
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 21 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04497831
Start Date
September 21 2020
End Date
September 21 2022
Last Update
August 4 2020
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