Clinical trial NCT04497831: Morphine for Dyspnea in Pulmonary Fibrosis
Official title: Determining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: "Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"


Eligibility criteria: 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:

    1. postmenopausal (no menses for 12 months without an alternative medical cause)
    2. sterile
    3. using acceptable contraception and agree to exclude pregnancy with pregnancy test in the beginning of the hospitalization

Exclusion Criteria:

* - 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

Primary outcomes:
measure: 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
timeFrame: Breathlessness during daily, normal activities will be measured with VAS 1 hour before nebulization and 4 hours after
Secondary outcomes:
measure: Secondary end point
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: