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

Medical University of Gdansk0 sites20 target enrollmentSeptember 21, 2020

ConditionsIdiopathic Pulmonary Fibrosis (IPF)

InterventionsMorphine hydrochloride Placebo

Overview

Phase: Phase 3
Intervention: Morphine hydrochloride
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: Medical University of Gdansk
Enrollment: 20
Primary Endpoint: 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
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 21, 2020

End Date

September 21, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Medical University of Gdansk

Responsible Party

Sponsor

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)
•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)

Arms & Interventions

Study Drug

Morphine hydrochloride

Intervention: Morphine hydrochloride

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)