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Morphine for Dyspnea in Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Morphine hydrochloride
Placebo
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Study Drug

    Placebo

    Arm Description

    Morphine hydrochloride

    Placebo

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Secondary end point
    Secondary end points are: reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) following six minute walking test (6MWT) performed after nebulization improvement of 6MWT distance by ≥30 m reduction of cough severity by ≥17 mm at 100 mm visual analogue scale (VAS) after nebulization, during normal activities reduction of chest pain severity by ≥19 mm at 100 mm visual analogue scale (VAS) after nebulization, during normal activities reduction of cough severity by ≥17 mm at 100 mm visual analogue scale (VAS) during six minute walking test (6MWT) performed after nebulization reduction of chest pain severity by ≥19 mm at 100 mm visual analogue scale (VAS) following six minute walking test (6MWT) performed after nebulization

    Full Information

    First Posted
    July 25, 2020
    Last Updated
    July 30, 2020
    Sponsor
    Medical University of Gdansk
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04497831
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 21, 2020 (Anticipated)
    Primary Completion Date
    September 21, 2022 (Anticipated)
    Study Completion Date
    September 21, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Gdansk

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Pulmonary Fibrosis (IPF)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    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
    Masking
    ParticipantInvestigator
    Masking Description
    Double blind
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Drug
    Arm Type
    Experimental
    Arm Description
    Morphine hydrochloride
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine hydrochloride
    Intervention Description
    5 mg milligram(s) per day per two days of dosage
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Inhalation use
    Primary Outcome Measure Information:
    Title
    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
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Secondary end point
    Description
    Secondary end points are: reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) following six minute walking test (6MWT) performed after nebulization improvement of 6MWT distance by ≥30 m reduction of cough severity by ≥17 mm at 100 mm visual analogue scale (VAS) after nebulization, during normal activities reduction of chest pain severity by ≥19 mm at 100 mm visual analogue scale (VAS) after nebulization, during normal activities reduction of cough severity by ≥17 mm at 100 mm visual analogue scale (VAS) during six minute walking test (6MWT) performed after nebulization reduction of chest pain severity by ≥19 mm at 100 mm visual analogue scale (VAS) following six minute walking test (6MWT) performed after nebulization
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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: postmenopausal (no menses for 12 months without an alternative medical cause) sterile 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

    12. IPD Sharing Statement

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    Morphine for Dyspnea in Pulmonary Fibrosis

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