Morphine for Dyspnea in Pulmonary Fibrosis

July 30, 2020 updated by: Medical University of Gdansk

Determining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary Fibrosis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Inhalation use
Experimental: Study Drug
Morphine hydrochloride
Drug: Morphine hydrochloride
5 mg milligram(s) per day per two days of dosage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: Breathlessness during daily, normal activities will be measured with VAS 1 hour before nebulization and 4 hours after
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary end point
Time Frame: 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

Secondary end points are:

  1. reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) following six minute walking test (6MWT) performed after nebulization
  2. improvement of 6MWT distance by ≥30 m
  3. reduction of cough severity by ≥17 mm at 100 mm visual analogue scale (VAS) after nebulization, during normal activities
  4. reduction of chest pain severity by ≥19 mm at 100 mm visual analogue scale (VAS) after nebulization, during normal activities
  5. reduction of cough severity by ≥17 mm at 100 mm visual analogue scale (VAS) during six minute walking test (6MWT) performed after nebulization
  6. reduction of chest pain severity by ≥19 mm at 100 mm visual analogue scale (VAS) following six minute walking test (6MWT) performed after nebulization
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NKBBN/433/2018
  • 2019-000662-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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