Morphine for Dyspnea in Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2022-09-21

Brief Summary

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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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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind

Study Groups

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Study Drug

Morphine hydrochloride

Group Type EXPERIMENTAL

Morphine hydrochloride

Intervention Type DRUG

5 mg milligram(s) per day per two days of dosage

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhalation use

Interventions

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Morphine hydrochloride

5 mg milligram(s) per day per two days of dosage

Intervention Type DRUG

Placebo

Inhalation use

Intervention Type DRUG

Eligibility Criteria

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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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No