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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000662-37 | EudraCT Number |
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"Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug | Experimental | Morphine hydrochloride |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine hydrochloride | Drug | 5 mg milligram(s) per day per two days of dosage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary end point is a reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) after nebulization, during daily, normal activities | The primary end point is a reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) after nebulization, during daily, normal activities | Breathlessness during daily, normal activities will be measured with VAS 1 hour before nebulization and 4 hours after |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary end point | Secondary end points are:
|
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Inclusion Criteria:
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:
Exclusion Criteria:
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
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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The study is a randomized, double-blind, placebo-controlled analysis conducted with crossover arms. The study consists of two treatment periods lasting a total of 5 days: 2 days of nebulization with 0.9% NaCl and 2 days of nebulization with 2.0% morphine hydrochloride solution separated by 1 day intended for elimination of the drug from the body (wash-out). The order of treatment periods (morphine -> placebo, placebo -> morphine) will be randomized for each patient by a hospital pharmacist using online software: Research Randomizer 4.0. The draw will assign the participant to one of two sequences:
A. 2 days - 0.9% NaCl; 1 day - wash-out; 2 days - morphine hydrochloride. B. 2 days - morphine hydrochloride; 1 day - wash-out; 2 days - 0.9% NaCl
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Double blind
| Placebo |
| Drug |
Inhalation use |
|
| Cough and chest pain severity during normal activities will be assessed with VAS 1h before nebulization and 4 hours after Six minute walking test, along with breathlessness, cough and chest pain assessment in VAS, will be performed 1h before nebuli |