Morphine for Dyspnea in Pulmonary Fibrosis

Medical University of Gdansk

Status and phase: Unknown; Phase 3

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Drug: Placebo; Drug: Morphine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04497831

2019-000662-37 (EudraCT Number)

NKBBN/433/2018

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Study Drug

Experimental group

Description:

Morphine hydrochloride

Treatment:

Drug: Morphine hydrochloride

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo