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Morphine for Dyspnea in Pulmonary Fibrosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04497831
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Medical University of Gdansk
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Idiopathic Pulmonary Fibrosis (IPF)
Arms & Interventions

Arms

Experimental: Study Drug

Morphine hydrochloride

Placebo Comparator: Placebo

Placebo

Interventions

Drug: - Morphine hydrochloride

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

Drug: - Placebo

Inhalation use

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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