Morphine for Dyspnea in Pulmonary Fibrosis

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: Unknown
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: Morphine hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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

Outcome Measure	Measure Description	Time Frame
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	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

• Sponsor: Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (Anticipated): September 21, 2020
• Primary Completion (Anticipated): September 21, 2022
• Study Completion (Anticipated): September 21, 2022

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Dyspnea; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID 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