Morphine for Dyspnea in Pulmonary Fibrosis

NCT04497831 | Unknown Phase 3

• 2 other identifiers: NKBBN/433/20182019-000662-37
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (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

  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 Outcomes (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

Study Arms (2)

Study Drug

EXPERIMENTAL

Morphine hydrochloride

Drug: Morphine hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Morphine hydrochloride DRUG

5 mg milligram(s) per day per two days of dosage

Study Drug

Placebo DRUG

Inhalation use

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 4, 2020
• Study Start: September 21, 2020
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: August 4, 2020

Record last verified: 2020-07