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Morphine for Dyspnea in Pulmonary Fibrosis

Sponsor
Medical University of Gdansk (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04497831
Collaborator
(none)
20
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Morphine hydrochloride
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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% NaClThe 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: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:
Double (Participant, Investigator)
Masking Description:
Double blind
Primary Purpose:
Treatment
Official Title:
Determining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary Fibrosis
Anticipated Study Start Date :
Sep 21, 2020
Anticipated Primary Completion Date :
Sep 21, 2022
Anticipated Study Completion Date :
Sep 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Drug

Morphine hydrochloride

Drug: Morphine hydrochloride
5 mg milligram(s) per day per two days of dosage
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Inhalation use

Outcome Measures

Primary Outcome Measures

  1. 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]

    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

  1. Secondary end point [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: 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Gdansk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT04497831
Other Study ID Numbers:
  • NKBBN/433/2018
  • 2019-000662-37
First Posted:
Aug 4, 2020
Last Update Posted:
Aug 4, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Dyspnea
Fibrosis
Morphine

Study Results

No Results Posted as of Aug 4, 2020