Morphine for Dyspnea in Pulmonary Fibrosis

Phase 3

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: Morphine hydrochloride; Drug: Placebo

• Registration Number: NCT04497831
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-25
• Study First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-04
• Study Start: 2020-09-21
• Primary Completion: 2022-09-21
• Study Completion: 2022-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study Drug	Morphine hydrochloride	Morphine hydrochloride
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: 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