Interstitial Lung DiseasePhase 4MORPHILDNCT02622022
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
A Phase 4 study testing Morphine hydrochloride in people with Interstitial Lung Disease and Dyspnea, run by University of Aarhus at 1 site in Denmark.
Trial summary
36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo. VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Interstitial Lung Disease, Dyspnea, Morphine
- What is being tested?
- Morphine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to 6 Feb 2019
- Phase
- Phase 4
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestous, drug induced ILD, unclassified ILD)
- Dyspnea corresponding to Medial Research Councils (MRC) dyspnea score ≥ 3
- Written consent
- Age ≥ 18 years
- Competent
- For fertile women: Negative pregnancy test
- For fertile and sexually active participants: Use of safe anti-conceptionals
Who cannot join
- Ongoing infection
- Decreased lung function to a degree which makes any form of respiratory depression life threatening
- Treatment with morphine or morphine analogues
- Allergy towards morphine hydrochloride
Trial locations and contacts
1 site in 1 country.
About this study
36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo.
VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)
- Conditions
- Interstitial Lung Disease, Dyspnea, Morphine
- Being tested
- Morphine hydrochloride, Placebo
- Keywords
- randomised, placebo controlled, clinical trial
- Medical subject headings
- Lung Diseases, Interstitial, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine hydrochlorideDrug
Also called Placebo
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | 18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily Receives: Drug: Morphine hydrochloride |
| Placebo | Placebo comparator | 18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS dyspnea score
Measured: 1 week
Secondary outcomes (5)
Oxygen saturation
Peripheral oxygen saturation will be measured after first dose of morphine and placebo as well as after 1 week follow up
Measured: 1 hour and 1 week
K-bild questionnaire
questionnaire regarding interstitial lung specific life quality
Measured: 1 week
GAD-7 questionnaire
VAlidatet score for anxiety and depression
Measured: 1 week
6 min walk test
Measured: 1 hour and 1 week
Leicester Score
cough related score
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Skanderbog Apotek
- Responsible party
- Principal investigator, Charlotte Andersen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622022
- Sponsor's protocol ID
- 2015-002533-22
- Other IDs
- 2015
- Acronym
- MORPHILD
- Status last verified
- Apr 2019
- First submitted
- 2 Dec 2015
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kronborg-White S, Andersen CU, Kohberg C, Hilberg O, Bendstrup E. Palliation of chronic breathlessness with morphine in patients with fibrotic interstitial lung disease - a randomised placebo-controlled trial. Respir Res. 2020 Jul 23;21(1):195. doi: 10.1186/s12931-020-01452-7.
PubMed 32703194
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02622022
- Acronym / sponsor ID
- MORPHILD / 2015-002533-22
- Conditions
- Interstitial Lung Disease, Dyspnea, Morphine
- Keywords
- randomised, placebo controlled, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Skanderbog Apotek
- Study start
- Jan 2016
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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.
36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo.
VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: Morphine hydrochloride18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily |
| Placebo | Placebo comparator | Other: Placebo18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestous, drug induced ILD, unclassified ILD)
- Dyspnea corresponding to Medial Research Councils (MRC) dyspnea score ≥ 3
- Written consent
- Age ≥ 18 years
- Competent
Key exclusion criteria (4 listed)
- Ongoing infection
- Decreased lung function to a degree which makes any form of respiratory depression life threatening
- Treatment with morphine or morphine analogues
- Allergy towards morphine hydrochloride
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 hydrochlorideAlso: Placebo | Drug | Morphine |
| Placebo | Other | Placebo |
Primary outcome
VAS dyspnea score
Time frame: 1 week
5 secondary outcomes
Oxygen saturation
Time frame: 1 hour and 1 week
K-bild questionnaire
Time frame: 1 week
GAD-7 questionnaire
Time frame: 1 week
6 min walk test
Time frame: 1 hour and 1 week
Leicester Score
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 32703194Kronborg-White S, Andersen CU, Kohberg C, Hilberg O, Bendstrup E. Palliation of chronic breathlessness with morphine in patients with fibrotic interstitial lung disease - a randomised placebo-controlled trial. Respir Res. 2020 Jul 23;21(1):195. doi: 10.1186/s12931-020-01452-7.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine hydrochloride in people with Interstitial Lung Disease and Dyspnea, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS dyspnea score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622022, which also lists 1 linked publication.
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 10 Apr 2019.