Idiopathic Pulmonary Fibrosis (IPF)Phase 3NCT04497831
Morphine for Dyspnea in Pulmonary Fibrosis
A Phase 3 study testing Morphine hydrochloride in people with Idiopathic Pulmonary Fibrosis (IPF), run by Medical University of Gdansk.
Trial summary
"Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Morphine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2020to 21 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- - 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
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- 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
About this study
Official title: 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"
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Morphine hydrochloride, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine hydrochlorideDrug
5 mg milligram(s) per day per two days of dosage
PlaceboDrug
Inhalation use
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | Morphine hydrochloride Receives: Drug: Morphine hydrochloride |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Breathlessness during daily, normal activities will be measured with VAS 1 hour before nebulization and 4 hours after
Secondary outcomes (1)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start21 Sep 2020 (estimated)
- Primary completion21 Sep 2022 (estimated)
- Study completion21 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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% NaCl
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497831
- Sponsor's protocol ID
- NKBBN/433/2018
- Other IDs
- 2019-000662-37, 2019
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04497831
- Acronym / sponsor ID
- NKBBN/433/2018
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 21 Sep 2020 (estimated)
- Primary completion
- 21 Sep 2022 (estimated)
- Study completion
- 21 Sep 2022 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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% NaCl
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Experimental | Drug: Morphine hydrochlorideMorphine hydrochloride |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- IPF diagnosis in accordance with guidelines
Key exclusion criteria (27 listed)
- - other coexisting severe chronic lung diseases
- absolute contraindications to six-minute-walking-test according to
- < 7-10 days since coronary interventions due to STEMI
- < 24 h since planned coronary intervention
- myocarditis/pericarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine hydrochloride5 mg milligram(s) per day per two days of dosage | Drug | Study Drug |
| PlaceboInhalation use | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Secondary end point
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine hydrochloride in people with Idiopathic Pulmonary Fibrosis (IPF), run by Medical University of Gdansk.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.